Medical device recalls for August 2014

Oct 10, 2023

September 3, 2014 By MassDevice Contributors Network

August SummaryClass I recalls: 244Class II recalls: 171

Date Posted, Recalling Manufacturer, Trade Name/Product, Reason for Recall

Aug-08-2014 Enhancement Medical; LLC Enhancement Medical expression – Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint; intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However; Expression is currently being used off-label as a subcutaneously injected dermal filler. Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to include all lots of product.

Aug-14-2014 Cardiovascular Systems; Inc. Diamondback 360 Peripheral Orbital Atherectomy System. – CSI Cardiovascular Systems; Inc.; Diamondback 360 Peripheral Orbital Atherectomy System; Model Number DBP-125MICRO145; Part Number 7-10003.The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking; fracture; and release particulate during use.

Aug-20-2014 Synthes; Inc. DePuy Synthes Craniomaxillofacial Distraction System – DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.

Aug-20-2014 Childrens Medical Ventures Gel-E Donut; Squishon 2 – Gel-E Donut; Squishon 2 gel pillowsProduct Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated. The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi; which are commonly found molds.

Aug-27-2014 Cook Inc. CloverSnare 4-Loop Vascular Retrieval Snare – CloverSnare 4-Loop Vascular Retrieval Snare.Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box.The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects; including but not limited to; wire guides; coils; balloons; catheters; and filters. This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.

Aug-28-2014 Smiths Medical ASD; Inc. Portex Endotracheal Tube Holders – 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy; LDS 15mm ConnPediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing asuction catheter.

Aug-28-2014 Smiths Medical ASD; Inc. Portex Endotracheal Tube Holders – H4052 Endo Tube Holder; Pedi 3.0mmPediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing asuction catheter.

Aug-28-2014 Smiths Medical ASD; Inc. Portex Endotracheal Tube Holders – H4051 Endo Tube Holder; Pedi 2.5mmPediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing asuction catheter.

Aug-28-2014 Smiths Medical ASD; Inc. Portex Endotracheal Tube Holders – H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy; 15mm Conn; HolderPediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing asuction catheter.

Aug-28-2014 Smiths Medical ASD; Inc. Portex Endotracheal Tube Holders – H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy;15mm Conn; Holder Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing asuction catheter.

Aug-28-2014 Smiths Medical ASD; Inc. Portex Endotracheal Tube Holders – H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy; LDS 15mm ConnPediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing asuction catheter.

Aug-29-2014 Customed; Inc Customed – Face Pack- BOD; code 900-3027; contains:(2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill(2) TOWELS ABSORBENT 15" X 20"(1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16"(1 ) TRAY HALF DEEP(1) COUNTER NEEDLE/BLADE 20C FOAM/MAG(1) COVER MAYO STAND REINFORCED(1 ) SHEET ENT SPLIT 110" X 77"(1 ) COVER TABLE REINFORCED 44" X 78"(20) GAUZE SPONGES 4" X 4" 12PLY(6) TOWELS CLOTH HUCK C BLUE(1 ) CUP DENTURE 8oz TEAL WITH LID(1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK(2) LITE GLOVEProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROTOMY PACK – CUSTOMED- (1) BAG SUTURE FLORAL(2) TOWEL ABSORBENT 15" X 20"(1) MAYO STAND COVER REINFORCED(1) DRAPE T LAPAROTOMY STD SMS(2) SHEET DRAPE 42" X 57"(1) TABLE COVER REINFORCED 50" X 90"(4) DRAPE UTILITY WITH TAPEEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM(I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF(I) DRAPE VIDEO CAMERA 13cm X 244 em LIF( I ) DRAPE LAP ABDOM W/POUCH 1 02"" X 1 22"" X 78"" STD SMS(2) LEGGINGS W/7"" CUFF 30" X 42"" ( I ) SAFETY SCALP EL # II S/STEEL( I ) GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III ( I ) TABLE COY ER REINFORCED 50"" X 90"" LIF(4) DRAPE UTILITY WIT APE LIF(2) DRAPE SI-IEET 42"" X 57"" SMS(I) TUBE SUCTION CONNECT Y."" X 1 2′ LIF( I ) MAYO STAND COYER REINFORCED LIF (1 0) GAUZE SPONGE 4"" X 4"" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5"" X 20"" LIF(2) LITE GLOVE( I ) DRAPE UNDERBUTTOCK W/ PO UCl-144"" X 35"" (2) SYRINGE I Occ W/0 NEEDLE LILOCK LIF(2) SPEC IMEN CONTA INER 4oz W/LID & LABEL (1 5) LAP SPONGE PREWASH 18" X 1 8"" XRD LIF ( I ) PVP PAINT 8"" STICK SPONGE( I ) UTILITY BOWL QUART 32oz LIF ( I ) ELECTRODE DUAL DEPRES( I) DRESSING OPSITE POST PO 2!12 X 2""( I ) MERLINO SK IN PREP APPLIC. 39ML LIF(3) GOWM XL SMS IMPERVIOUS REINFORCED LIF( I ) CORD LAPAROSCOPY MONOPOLAR FOOD SWICH ING(1) FOLEY CATHETER KIT CONTAINING:(I) CATHETER 1 6FR FOLEY 2WAY; Sec(I) PYP TR IPLE SWABSTICK IODOPHOR (2) SWABSTICK DRY COTTON( I ) SYR I NGE IOcc WATERFREFIL LIF(2) GLOVE MED FREETOUCH YYN I L P/F (I) TOWEL3PLYPOLY 17"" X 18""(I) DRAPE 4"" FENESTRATED 18"" X 26"" (I) LABEL lD PATIENT(I) JELLY LUBRI CATING FIVE GRAM( I ) URINARY BAG DRAINAGE 2000ML ANTI-REFLUX LIF ( I ) TRAY SBS( I ) WRAPPER 24"" X 24""Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Tummy Tuck Pack- FJG; code 900-3114; contains:(2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill(2) TOWEL ABSORBENT 15" X 20"(1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER(1) NEEDLE HYPODERMIC 22G X 1 Y2(2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK(1) COUNTER NEEDLE & BLADE 20C FOAM/MAG(2) BOWL UTILITY QUART 32oz.(1) COVER MAYO STAND REINFORCED(2) MARKER SKIN WITH RULER(1) RULER(1) COVER TABLE REINFORCED 50" X 90"(2) CUP DENTURE 8oz TEAL WITH LID(6) TOWEL CLOTH HUCK BLUE(1) TUBE SUCTION CONNECT X" X 12′(1) YANKAUER SUCTION TUBE WITHOUT VENT(1) SHEET% DRAPE REINFORCED 60" X 77"(4) DRAPE UTILITY WITH TAPE(1 0) LAP SPONGE PREWASH 18" X 18" XRD(1) BLADE SURG. #15 CARBON STEEL(1) BLADE SURG. #1 0 CARBON STEEL(1) SYRINGE BULB 60cc(2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #6.5 P/F(2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F(1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7.5 P/F(1) SKIN STAPLE 35 WIDE(1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS(2) DRAPE SIDE 42" X 76" WITH TAPE(1) DRAPE BOTIOM ABS REINFORCED 71" X 62" STD SMS WITH TAPE(1 0) GAUZE SPONGE 4" X 4" 16 PLY(1) PK. STRIP STERI CLOSURE W X 4"Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Obstetrical Surgical pack; code 900-2940; contains:(1) BLANKET RECEIVING 100 COTTON(3) TOWEL ABSORBENT 15 X 20 LIF(10) GAUZE SPONGE 4 X 4 16PLY XRD LIF(1) SYRINGE EAR/ULCER 2oz. LIF(1) DRAPE ABDOMINAL WITH TAPE 40X54 LIF(2) LEGGINS W/7" CUFF 30X42 L/F(1) GOWN XL SMS IMPERVIOUS REINFORCED LIF(1) OB PAD WRAP OVERNIGHT(1) TABLE COVER REINFORCED 50X90 LIF(1) DRAPE UNDERBUTTOCK W/POUCH 44X35"(1) CLAMP UMBILICAL CORD LIF(1) BOWL PLASTIC 80oz. LIF(1) LID FOR BOWL 80oz. CLEAR LIF(1) BEANNIES BABY(5) LAP SPONGE PREWASH 18X18XRD(1) MAYO TRAY SMALL(1) DRAPE SHEET 41X58 SMS LIF(1) UNDERPAD 36X36 BEIGE(1) VAGINAL PACKING XRD 4X36 8PLY 100% COTTON(10) GAUZE SPONGE 4X4 16PLY LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAP AROSCOPY PACK – (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF(1) MAYO STAND COVER REINFORCED L/F(4) ADHESIVE BANDAGE%" X 3" ST. LIF(1) TABLE COVER REINFORCED 50" X 90" LIF(2) GOWN IMPERVIOUS REINFORCED LARGE SMS(2) TOWEL ABSORBENT 15" X 20" LIF(1) DRAPE LASER CAMERA W/EL 6" X 96" LIF(2) LITE GLOVE LIF(1) TUBE SUCTION CONNECTING W X 12′ LIF(1) DRAPE LAP WITH POUCH 102" X 121 " X 78" STD SMS(1) BLADE SURGICAL #11 STAINLESS STEEL(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF(4) DRAPE UTILITY WITH TAPE L/F(1) BAG SUTURE FLORAL(1) TUR Y SET; 2 LEAD L/F(2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF(1) GOWN STANDARD LARGE SMS VELCRO NECK(1) TUBE SUCTION CONNECT 3/16" X 12′ LIF(1) Pk. STERI STRIP LAP. LATEX(1) CONTAINER SPECIMEN 4oz WITH LID & LABEL(1) CAUTERY PENCIL ROCKER SWITCH LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – OB PACK – (2) EXAM GLOVES MED.(1 0) GAUZE SPONGES 4" X 4" 12PL Y(2) LEGGINS W/ 7" CUFF(2) DRAPE SHEET SMS(1) ABDOMINAL DRAPE W/TAPE(1) PLASTIC BOWL W/Lid 70 oz.(1) EAR/ULCER SYRINGE 2oz. L/Free(1) UMBILICAL CORD CLAMP(1) BABY BEANNIES(1) PVP SCRUB 8" STICK SPONGES(1) MEASURE DISP. PAPER TAPE 24"(1) IMP .REINFORCED GOWN XLge. SMSSTERILE(1) TABLE COVER Reinf. L/Free(1) SYRINGE 1cc W/NDL. 25G X 5/8 SLIP TIP L/Free(2) PAD OBSTETRICAL XLGE ST.(1) UNDERBUTTOCK DRAPE W/POUCH(1) SYRINGE 10cc W/0 NDL. L/Free(1) SYRINGE 20cc W/ONDL. L/Lock L/Free(1) FEEDING TUBE 8 Fr. 15" LONG(1) BABY BLANKET IMP. POLY ABS.(1) NEEDLE HYPODERMIC 23GA X 1"(6) ABSORBENT TOWELS L/Free(1) WRAPPER 24" X 24"EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – NEURO PACK – (1) CAUTERY TIP POLISHER LIF(4) DRAPE UTILITY WITH TAPE LIF(1) INSTRUMENT POUCH(10) LAP SPONGE PRE-WASH XRD(1) Pk. SURGICAL STRIP W’ X 6"(2) UTILITY BOWL 32oz(1) MAYO TRAY LARGE(9) SHEET DRAPE 41 " X 69" MEDIUM LIF(1) NEEDLE HYPODERMIC 18G X 1 LIF(3) CONTAINER SPECIMEN 4oz WITH LID & LABEL(2) Pr. SURGICAL GLOVES 7 Y2(2) Pr. SURGICAL GLOVES 8(2) EAR ULCER SYRINGE 2oz LIF(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF(1) SHEET MINOR LAP 102" X 121" X 78"(1) SAFETY SCALPEL #10(2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF(4) CLOTH HUCK TOWELS BLUE(1) PENCIL CAUTERY ROCKER SWITCH(2) LEGGINS W/7" CUFF 30" X 42"(1) DRAPE% ECONOMY 53" X 77" LIF(1) Pk. SURGICAL STRIP ‘X" X 6"(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF(1) TABLE COVER REINFORCED 50" X 90" LIF(2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F(2) ROUND WASH BASIN 6QT(2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE(2) Pr. SURGICAL GLOVES 7(1) SKIN MARKER WITH RULER LIF(1) Pk. STERI STRIP CLOSURE %"X 4" LIF(1) TUBE SUCTION CONNECT. ‘X" X 12’ LIF(1) SAFETY SCALPEL #15(1) SAFETY SCALPEL #11L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Face Pack MRT; product code 900-2654; contains:(2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF(2) TOWELS ABSORBENT 15 X 20 LIF(1) DRAPE INST. MAGNETIC 10 X 16 LIF(1) TRAY HALF DEEP(1) COVER MAYO STAND REINFORCED LIF(1) SHEET ENT SPLIT 110 X 77 SMS LIF(1) COVER TABLE REINFORCED 44" X 78" LIF(20) GAUZE SPONGES 4 X 4 12PLY L/F(6) TOWELS CLOTH HUCK C BLUE L/F(2) TIP ABSORB. APPLIC STICK SPONGE LIF(1) STRIP STERI CLOSURE LIF(1) CUP DENTURE 8oz. TEAL WITH LID(1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF(2) SYRINGE 10ML DARK GREEN(1) SYRINGE 10ML YELLOW L/F(1) LITE GLOVE LIF(1) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Breast Pack MRT; code 900-2658; contains:( 1) BULB SYRINGE 60cc(2) GOWN SOFT SMS STD XLGE SET IN SLEEVE( 1) CAUTERY PENCIL PUSH BOTTOM(2) SYRINGE 10cc W/0 NEEDLE LUER LOCK( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG( 1) UTILITY BOWL QUART 32oz( 1) MAYO STAND COVER REINFORCED( 1) TABLE COVER REINFORCED 50 X 90( 1) DRAPE BREAST/CHEST SMS( 1) YANKAUER SUCTION TUBE W/0 VENT( 1) TUBE SUCTION CONNECT Y( 1) RULER 6 CLEAR(6) TOWEL CLOTH HUCK C (BLUE)(2) TOWEL ABSORBENT 15 X 20(2) SKIN MARKER INK W/ LABEL( 1) DENTURE CUP 8oz W/LID(2) LITE GLOVESProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF(1) COVER MAYO STAND REINFORCED UF(2) TOWEL ABSORBENT 15" X 20" UF(1 0) GAUZE SPONGES XRD 4" X 4"-12PL Y(2) DRAPE SHEET 41 " X 58" SMS UF(4) DRAPE UTILITY WITH TAPE L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – EAR PACKCONTENTS:( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I ‘h( I ) WASH BASIN ROUND 6QT( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P CLOSURE ‘h"" X 4""( I) SYRINGE 3cc WITHOUT NEEDLE LILOCK (2) SYRINGE I ML WITHOUT NEEDLE LILOCK (I) CAUTERY TIP POLISHER(I) SHEET ENT SPLIT 110"" X 77"" SMS( I ) GOWN I MP XTRA REINF. SMS XLT/ W LEVEL I V (2) LITE GLOVE(1 2) TOWELS CLOTH HUCK (BLUE)( I ) TUBE SUCTION CONNECT W’ X 1 2′ (I) EAR ULCER SYRINGE 2oz(I) TABLE COYER REINFORCED 50"" X 90""( I) UTILITY BOWL 16oz(4) APPLICATOR COTTON 6"" WOOD (2) STRJPS TAPE 24"" X 4""( I ) GOWN LGE SMS I MPERVIOUS REINFORCED ( I ) WIPE INSTRUMENT LMM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED( I ) NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I ) SYRINGE I Occ WITHOUT NEEDLE LILOCK( I ) MAYOTRAY SMALL( I ) SYRINGE I Occ TI P CONTROL LUER LOCK ( I ) DRAPE M ICROCOSPE LE I CA 42 X 105( I ) TI ME OUT BEACON NON WOVEN(I) BLADE M IN IATURE CARBON STEEL (10) GAUZE SPONGE 4"" X 4"" 1 6PLY XRD (I) SK I N MARKER INK W/8 LABEL(2) NEEDLE HYPODERM I C 27G X I W’ONE PACK WET SK IN W ITH CONTENTS: ( I ) WRAPPER SMS 30"" X 30""(2) COTTON TIP APPLICATOR 6"" WOOD (2) GLOVE MED FREETOUCH VYNIL P/F (6) SPONGE W ING SMALL(4) TOWELS ABSORBENT 1 5"" X 20""(3) TIP ABSORB. APPLICATOR STI CK SPONGE ( I ) PVP IODOPHOR PAINT 4oz. BOTTLE(I) PVP SCRUB SOLUTION 4oz. BOTTLE (I) TRAY 3/COMPARTMENTProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – NEURO PACKCONTENTS:(4) TOWEL ABSOSRBENT 15"" X 20"" LIF ( I ) BAG BI OH AZARD 30"" X 37""(2) MAYO STAND COYER REINFORCED UF(20) GAUZE SPONGE 4"" X 4"" 1 6PLY XRD UF( I ) CAUTERY POLISHER TIP LIF( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE(8) TOWELS CLOTH I-l UCK (BLUE) (2) WASH BASIN ROUND 6QT( I ) NEEDLE HYPODERMIC 1 8G X I \12 ST. (2) UTI LITY BOWL QUART 32oz.(2) BULB SYRINGE 60cc LIF(2) NEEDLE & BLADE COUNTER; IOC M/CLEAR LIF (2) PVP SCRUB 8" STICK SPONGE ST.(I)SKIN STAPLE 35 WIDE ST. LIF(2) SYRINGE 60ML W/0 NEEDLE LILOCK LIF(2) LITE GLOVE(I) TABLE COYER BTC 79"" X 110"" HD FULL COVERAGE LIF (2) TUBE SUCTION CONNECT. W’ X 1 2′ LIF (4) DRAPE UTILI TY WIT APE LIF(5) LAP SPONGE PREWASH 1 8"" X 1 8"" XRD LIF (I) CAUTERY PENCIL ROCKER SWITCH UF (2) BLADE SURG I CA L # I O CARBON STEEL(I) BLADE SURG I CAL#1 5 CARBON STEEL(I) SKIN MARKER INK W/8 LABEL (3) UTI LITY BOWL 1 6oz. L/F(2) PVP PAINT 8"" STICK SPONGE ST. (7) DRAPE :V. ECONOMY 53"" X 77"" LIF(I)S UTURE BAG FLORAL(I) SY RINGE I Occ SLI P TI P ST. LIF(I) NEEDLE HYPODERM IC 22G X I \12 ST.(I) SOLUTION SURG I CAL DURAPREP 26M L LIF(I) GOWN SURG. REINFORCED LGE TOWEL/ WRAP(2) GOWN FAB REINFORCED X-LARGE SONTARA(I) DRAPE TLAPAROT. 1 02"" X 78"" X 1 21 "" STD SMSProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Knee Arthroscopy Pack; code 900-2718; contains:(1 0) GAUZE SPONGES 4 X 4 12PL Y(2) PADDING CAST SOFT ROLL 6 X 4yds.(1) GOBAN SELF-ADHERENT WRAP 6 X 5yds(3) PAD ABDOMINAL 8 X 7.5(1) DRESSING 1 X 8 XEROFORM PETROLAT(10) GAUZE SPONGES 4 X 4 16PLY XRD(3) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 (1) NEEDLE HYPODERMIC 22G X 1 (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK(1) SCALPEL W/HANDLE 11(1) SKIN MARKER W/RULER(9) LABELS FOR SKIN MARKERS(1) RULER(3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE(1) BANDAGE ELASTIC KNIT STD 10yds(1) BANDAGE ESMARK 6 X 9yds(8) TOWELS CLOTH HUCK BLUE(1) U – DRAPE 60 X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED(2) SOLUTION SURGICAL DURAPREP 26ML(3) TUBE SUCTION CONNECT (1) BOWL UTILITY 16oz.(1) COVER TABLE REINFORCED 50 X 90(2) GOWN SURGICAL REINFORCED X-LARGE(1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP(2) TOWELS ABSORBENT 15X 20(1) STOCKINETTE IMPERV 12 X 48(2) BAG PLASTIC 6 X 12(1) KNEE ARTHROSCOPY DRAPE(1) FILTER STRAW 5 MICRO(2) LITE GLOVEProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – EXTREMITY ARM PACKCONTENTS: (1) STOCKINETTE IMPERVIOUS 14"" X 48""(1) GOBAN SELF-ADHERENT WRAP 6"" X 5yds(3) BANDAGE ELASTIC 4"" X 5yds(1) BANDAGE ESMARK 6"" X 9 (1) UTILITY BOWL QUART 32oz(10) GAUZE SPONGE 4"" X 4"" 16PLY(1) TUBE SUCTION CONNECTX 12′(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (3) SCALPEL WITH HANDLE# 15 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN(1) LIGHT SHIELD(1) DRAPE INCISE ANTIMICROBIAL 23"" X 17""(2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR (1) U-DRAPE 60""X 70"" WITH TAPE SPLIT 6"" X 21"" (1) NEEDLE SPINAL ANESTH 18G X 3%(3) GOWN X-LARGE IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED(4) DR APE UTILITY WITH TAPE(6) TOWEL ABSORBENT 15"" X 20"" (3) DRAPE % ECONOMY 53"" X 77""(1) YANKAUER OPEN TIP CLEAR W/0 CN(1) CAUTERY TIP POLISHER (1) SUTURE BAG FLORAL(1) GOWN SURG REINFORCED X-LARGE TOWEL & WRAP(1) MERLING SKIN PREP APPLICATOR 39ML (1) SHEET HAND 146"" X 104"" X 91""(1) TABLE COVER REINFORCED 50"" X 90""Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – ARTHROSCOPY PACK I (1) CUSTOMEDCONTENTS: (1) TOWELS ABSORBENT 15"" X 20""(1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED(1) U – DRAPE 60"" X 70"" WITAPE SPLIT 6 X 21(1) SHEET SPLIT W/ADHESIVE 108"" X 77"" STD SMS (1) STOCKINETTE IMPERVIOUS 12"" X 48""(4) STRIPS TAPE 24"" X 4""(1) SUTURE BAG FLORAL(1) SHEET ARTHROSCOPY T STD SMS W/ POUCH (1) TABLE COVER REINFORCED 44"" X 78""(1) GOWN SURG. REINFORCED XLGE TOWEL I WRAPProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – EENT PACK ICUSTOMEDCONTENT: (2) TOWEL ABSORBENT 15"" X 20""(1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL(1) SHEET ENT SPLIT 110"" X 77"" SMS(1) TABLE COVER REINFORCED 50"" X 90"" (1) DRAPE HEAD W!TAPE 44"" X 26""(1) GOWN SURG. REINFORCED XLGE TOWEL/WRAPProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – BASIC PACK W/OUT GOWN-(1) TABLE COVER REINFORCED 50" X 90" UF(4) DRAPE UTILITY WITH TAPE UF(1) TOWEL ABSORBENT 15" x 20" L/F(1) SUTURE BAG FLORAL(1) DRAPE SHEET 42" X 57" SMSg~ SHEET o/. 57" X 63" REINFORCED SMS UFMAYO STAND COVER REINFORCED UFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – STRABISMUS & PLASTIC PACK – (1) TABLE COVER REINFORCED 44" X 78" UF(2) GOWN STANDARD LARGE SMS(3) TOWELS ABSORBENT 15" X 20" UF(1) MAYO STAND COVER REINFORCED UF(1) DRAPE SHEET 41" X 58" SMS(4) DRAPE UTILITY WITH TAPE L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – O.B. PACK – ( I) PVP SCRUB 8" STICK SPONGES( I) UNDERBUTTOCK DRAPE WITH POUCH(2) LEGGINS WITH 7" CUFF 30" x 42"( I) DRAPE ABDOMINAL WITH TAPE LIF( I) VAGINAL PACKING SPONGEXRD( I) BOWL WITH LID PLASTIC 80oz( I) RECEIVING BLANKET 100% COTTON(I) BABY BLANKET POLY ABSORBENT IMPERVIOUS(I) CORD UMBILICAL CLAMP(4) TOWELS ABSORBENT 15" x 20" LIF( I) UTILITY BOWL 16oz.(2) TRAY ORGANIZER FULL DEEP(3) T IP ABSORBENT APPLICATOR(2) GLOVES EXAM MEDIUM(2) GOWN LARGE SMS IMPERVIOUS REINFORCED(10) GAUZE SPONGE 4" X 4" 12PLY(2) PAD OBSTETRJCAL X-LARGE ST.(I) EAR ULCER SYRINGE 2oz. LIF(I) BABY BEANNIES(2) SHEET DRAPE 4 1" x 58" SMS LIF(I) SCISSORS UMBILICAL(I) TABLE COVER REINFORCED 50" x 90" LIF(2) WRAPPER 24" X 24" L/fProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Customed Cysto Tur Pack; convenience pack include multiple components: legging with cuff; drape cystoscopy; towel absorbent & table cover.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Basic Pack FPSC Florham Pack ; code 900-2969; contains:(1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD(1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill(1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15" X 20"(4) DRAPE UTILITY WITH TAPE (1) WRAPPER 24" X 24"(8) LABELS FOR SKIN MARKERS 1.25" X %" (2) LITES GLOVE(1) MARKER SKIN WITH RULER (1) BLADE SURGICAL# 15 CARBON STEEL(1) RULER(5) SPONGE LAP PREWASH 18" X 18" XRDProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CURATION KIT – CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y(4) ABSORBENT TIP APPLICATOR(4) PVP PREP SOLUTION 1 oz(1) CONTAINER SPECIMEN 4oz WITH LID & LABEL(2) EXAM GLOVES MEDIUM(1) WRAPPER 24" X 24" UF(1) PACKING TRAYEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90"(2) TOWELS ABSORBENT 15" X 20"(1) BABY BLANKET PRINTED(1) BOWL PLASTIC WITH LID 80oz.(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR(1) CORD UMBILICAL CLAMP(1) MUCUSTRAP 20cc; 10FR.(1) BOWL UTILITY 32oz(1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78"(1) TUBE SUCTION CONNECT. ~"X 12′(1) TIP CAUTERY POLISHER(1) PENCIL CAUTERY ROCKER SWITCH(2) GOWN IMPERVIOUS REINFORCED LARGE SMS(1) MAYO STAND COVER REINFORCED(10) LAP SPONGES PREWASH 18" X 18" XRD(1) BAG GLASSINE(2) SURGICAL BLADE #10 STAINLESS STEEL(1) EAR ULCER SYRINGE 2oz.(2) LIGHT GLOVE(1) BOWL UTILITY 16oz(4) DRAPE UTILITY WITH TAPE(2) DRAPE SHEET 41 " X 58" SMS(1) ELECTRODE DUAL DEPRES./GROUNDPADEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CENTRAL LINE DRAPE PACK1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free(1) DRAPE SHEET 41" X 58" SMS L/Free(1) CAP NURSE 21" GREEN BOUFFANT(1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED CIRC/ FENE (1) WRAPPER 24" X 24"GOWN LGE STANDARD SMS VELCRO NECK TOWELS ABSORBENT 15" X 20" L/FreeProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Lithotomy Pack III (3); code 900-2487; contains:(3) TOWEL ABSORBENT 15" X 20"(1) GOWN LARGE STANDARD SMS VELCRO NECK(2) LEGGINS WITH 7" CUFF 30" X 42"(1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35"(1) DRAPE ABDOMINAL WITH TAPE 40" X 54"(1) DRAPE UTILITY WITH TAPE(1) COVER TABLE REINFORCED 50" X 90"Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – CENTRAL LINE FULL BODY DRAPECUSTOMEDCONTENTS: (1) WRAPPER 30"" X 30""(2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg(2) CAP NURSE 21"" GREEN BOUFFANT (2) TOWELS ABSORBENT 15"" X 20""(2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41"" X 58"" SMS(1) DRAPE BRACHIAL ANGlO 44"" X 31"" REINFORCED 3"" ADHESIVE CIRCULAR FENESTRATIONProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – General Cosmetic Pack FCSC; Code 900-3113; contains:(1) COVER MAYO STAND REINFORCED LIF(10) LAP SPONGE PREWASH 18" X 18" XRD LIF(2) GOWN LARGE STANDARD SMS AAMIIII(1) TABLE COVER REINFORCED 50" X 90" LIF(2) TOWEL ABSORBENT 15" X 20" LIF(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF(1) SYRINGE BULB 60CC LIF(1) BLADE SURGICAL #15 CARBON STEEL(1) NEEDLE HYPODERMIC 18G X 1% LIF(6) TOWEL CLOTH HUCK BLUE LIF(4) DRAPE UTILITY WITH TAPE L/F(1) NEEDLE HYPODERMIC 25 X 1% L/F(1) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK LIF(2) SYRINGE 10CC WITHOUT NNEDEL LUER LOCK LIF(2) NEEDLE SPINAL ANESHT 20G X 3%" LIF(1) SKIN MARKER WITH RULER LIF(1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F(1) LITE GLOVE(1) DRAPE BREAST/CHEST SMS LIF(1) TUBE SUCTION CONNECT%" X 12′ LIF(10) GAUZE SPONGE 4" X 4" 16PLY L/F(2) GLOVE MEDIUM FREETOOUCH VYNIL POWDER FREE(1) TRAY 3/COMPARTMENT(1) WRAPPER 24" X 24" L/F(2) PK. SURG. GLOVE# 7% ENCORE POWDER FREE LATEXProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF(5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF(1) LITE GLOVE LIF(1) BAG SUTURE FLORAL(1) BLADE SURGICAL #1 0 CARBON STEEL(1) BLADE SURGICAL #15 CARBON STEEL(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF(1) CAUTERY TIP POLISHER LIF(1) BAG GLASSINE(1) TABLE COVER 44" X 90" L/F(2) DRAPE SHEET 41 " X 58" SMS(1) LAPAROTOMY DRAPE "T" 102" X 78" X 121" STD SMS(4) DRAPE UTILITY WITH TAPE LIF(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF(1) TUBE SUCTION CONECT W’ X 12′ LIF(3) ABSORBENT TOWELS 15" X 20" LIF(1) CAUTERY PENCIL PUSH BOTTON(1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP LEVEL Ill(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – OPEN HEART TRAY – – PACK A( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF(5) DRAPE % ECONOMY 53" X 77" LIF( 1) MAYO STAND COVER REINFORCED LIF(7) DRAPE UTILITY WITH TAPE L/F(8) HUCK CLOTH TOWELS WHITE L/F(20) HUCK CLOTH TOWELS BLUE LIF(1) MAYO TRAY LARGE LIF(1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF(6) 3/4 SHEET DRAPE REINFORCED LIF(2) STOCKINETTE 9" X 48" LIF(1) SPLIT SHEET BILATERAL 84" X 80" LIF(3) DRAPE SHEET 41" X 58" SMS LIF(4) Pr. GLOVES SURGEON #7 BIOGELOPEN HEART TRAY – HOSPITAL DAMAS – PACK B-(1) PLASTIC RULER 12" LONG (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F(1) Pk. PEANUT SPONGE DISSECTOR ST.(2) UTILITY BOWL 32 oz. LIF(1) SKIN MARKER WITH RULER LIF (2) UTILITY BOWL 16 oz. UF(3) BULB SYRINGE 60cc UF (1) MAYO TRAY SMALL L/F(2) YANKAUER SUCT. TUBE WITHOUT VENT UF (1) TRAY ORGANIZER FULL DEEP LIF(5) SAPHENOUS VEIN CANNULA LIF (40) LAP SPONGES PRE-WASH XRD UF(2) ELASTIC BANDAGE 6" X 5 yds. UF (2) SUTURE BAG FLORAL(2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF (1) BLADE SHARP ALL ARROUND 69(1) SURGICAL BLADE# 11 CARBON STEEL (4) LITE GLOVES UF(2) SURGICAL BLADE# 15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL(1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF (2) POUCH INSTRUMENT(2) SURGICAL BLADE# 10 CARBON STEEL (30) GAUZE SPONGES 4" X 4" 16 PLY XRD UF(2) CAUTERY PENCIL ROCKER SWITCH LIF (2) POLISHER CAUTERY TIP UF(1) LABEL SET; HEPARINE;SALINE (2) ELASTIC BANDAGE 4" X 5 yds. LIF(1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF(2) COTION GLOVE HEAVY DUTY (1) AORTIC MONITORING PRESS SET 5.0(1) CONNECTOR Y 3/8" X 3/8" X 3/8" LIF (2) NEEDLE HYPODERMIC 22G X 1 % LIF(1) BLADE 6.1 X 32.3 X 1.0MM (1) SQUARE TWO PIECE 500cc GRADUATE(2) CONNECTOR REDUCER (1) NEEDLE BLADE/KNIFE 3.0MMEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – UMBILICAL VESSEL CATHETER KIT – CUSTOMED-(1) PAPER TAPE MEASURE DISP. 24"(1) FENESTRATED DRAPE 18" x 26" LIF(1) NEEDLE HOLDER BAUMGARTNER 5"(2) HALSTED MOSQUITO CVD 5" SERRAT(1) ADSON FORCEP TISS. Wff(1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF(6) GAUZE SPONGE 2" X 2" 8PL Y(6) GAUZE 4" X 4" 16PL Y(1) SYRINGE 1 cc TB SffiP(1) IRIS FORCEP SERR Y. CVD 4" WITH PROTECTOR TIP(1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP(1) SUTURE 3-0 BLK MONOFIL(1) TRAY ORGANIZER FULL DEEP(1) WRAPPER 30" X 30" L/F(1) PVP TRIPLE IODOPHOR SWABSTICK(1) TONGUE DEPRESSOR 6" WOOD(1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP(1) SCALPEL WITH HANDLE #11(1) MOSQUITO FORCEP STRAIGHT 5"(2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF(2) 3 PLY POLY TOWEL(1) UMBILICAL TAPE(1 ) PROBE GRONED & DISNEETNS 6" 2ML(1) EYE DRESSING EXT FINE POINT FULL(2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO(1) PLASTIC TRAY 2/COMPARTMENT(1) HALF TRAY(1) STOPCOCK 3 WAY LUER SLIPEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – ORTHOPEDIC PACK Ill (1) CUSTOMEDCONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4) DRAPE UTILITY WffAPE (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL(1) DRAPE TOP W/ADHESIVE 108"" X 50"" STD SMS (1) DRAPE ORTHOPEDIC SPLIT(1) U- DRAPE 60"" X 70"" WffAPE SPLIT 6 X 21 (1) TABLE COVER REINFORCED 50"" X 90""(1) GOWN SURG REINFORCED XLGE TOWEL I WRAP (1) STOCKINETIE IMPERVIOUS 12"" X 48""Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CESAREAN PACK – – (1) MAYO STAND COVER REINFORCED LIF(20) LAP SPONGES PRE-WASH XRD LIF(1) UMBILICAL CORD CLAMP LIF(1) COVER TABLE REINFORCED 50" X 90" LIF(1) SURGICAL DURAPREP SOLUTION 26ML LIF(1) BEANNIES BABY(1) POLISHER TIP CAUTERY LIF(1) LITE GLOVE L/F(1) CAUTERY PENCIL ROCKER SWITCH L/F(1) C-SECTION DRAPE WITH POUCH LIF(1) MAYO TRAY SMALL(1) YANKAUER SUCTION TUBE WITHOUT VENT L/F(1) BLADE SURGICAL #10 CARBON STEEL(2) BOWL UTILITY 32oz. LIF(2) PAD OBSTETRICAL X- LARGE LIF(5) TOWEL ABSORBENT 15" X 20" LIF(1) DRAPE SHEET 41" X 58" SMS LIF(1) TUBE SUCTION CONNECT. Y.." X 12′ LIF(1) EAR ULCER SYRINGE 2oz. LIF(2) GOWM IMPERVIOUS EXTRA REINFORCED X-LARGE(1) RECEIVING BLANKET 100% COTTON(2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – MINOR EXTREMITY PACK {2)CUSTOMEDCONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS ABSORBENT 15"" X 20""(1) MAYO STAND COVER REINFORCED (1) SHEET PLASTIC 44"" X 65""(1) DRAPE% ECONOMY 53"" X 77"" (1) DRAPE UTILITY WITH TAPE(1) BAG SUTURE FLORAL(1) SHEET EXTREMITY ABS 125"" X 85"" SMS(1) TABLE COVER REINFORCED 50"" X 90""(1) GOWN XL SMS IMPERVIOUS REINFORCEDProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – OPEN HEART TRAYPACK ACONTENTS: (1) TABLE COVER BTC 77"" X 110"" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F(3) TOWEL ABSORBENT 15"" X 20"" LIF(1) TABLE COVER REINFORCED 50"" X 90"" LIF (1) SPLIT SHEET BILATERAL 84"" X 80""(12) % SHEET 60"" X 77"" DRAPE REINFORCED LIF (1) MAYO TRAY LARGE(1) CV DRAPE SPLIT CARDIO WITH CLEAR ANEST. SC STD SMS (15) TOWELS CLOTH HUCK BLUE(4) TOWELS CLOTH HUCK WHITE(2) STOCKINETTE IMPERVIOUS 14"" X 48"" LIF (30) LAP SPONGE PREWASH 18"" X 18"" XRD LIF (1) WRAPPER 54"" X 54""(3) LITES GLOVE LIFOPEN HEART TRAYHOSPITAL HERMANOS MELENDEZPACKBCONTENTS: (1) TABLE COVER BTC 77"" X 110"" HD FULL COVERAGE LIF(1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (2) CATHETER THORACIC 32FR. STRAIGH(2) PENCIL CAUTERY ROCKER SWITCH LIF(3) TUBE SUCTION CONNECT W X 12′ LIF(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) LABEL SET; HEPARINE SALINE(2) CAUTERY TIP POLISHER LIF(1) TABLE COVER REINFORCED 50"" X 90"" LIF (1) BANDAGE ELASTIC 6"" X 5yds LIF(2) YANKAUER SUCTION TUBE WITHOUT VENT LIF(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST.(10) GAUZE SPONGE 4"" X 4"" 16PLY XRD LIF(1) NEEDLE HYPODERMIC 27G X %"" ST.(1) NEEDLE & BLADE COUNTER 60C MAG/MAG (2) BOWL UTILITY 16oz.(4) FEEDING TUBE 8FR; 15"" LONG (2) BULB SYRINGE 60cc(1) TRAY PLATFORM LARGE(1) SKIN MARKER WITH RULER(1) CATHETER 18FR SUCTION W/STRA LIF (1) WRAPPER 54"" X 54"" UF(1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (2) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #20 CARBON STEELOPEN HEART TRAYHOSPITAL HERMANOS MELENDEZPACKCCONTENTS: (9) TOWELS ABSORBENT 15"" X 20"" UF(6) GOWN FAB REINFORCED SONTARA X-LARGE(1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill(1) TABLE COVER REINFORCED 44"" X 78"" UFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY CHOLE PACK – (4) DRAPE UTILITY WITH TAPE LIF(2) ABSORBENT TOWELS 15" X 20" LIF(2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF(1) SURGICAL DURAPREP SOLUTION 26ml LIF(1) TUR Y SET 81 "2.1M REGULAR CLAM ST.(1) DRAPE LASER CAMERA W/EL 6" X 96"(1) LAPAROSCOPY ABDOMINAL DRAPE W/POUCH L/F(1) TABLE COVER 44" X 90"(1) MAYO STAND REINFORCED L/F(1) SURGICAL BLADE # 11 CARBON STEEL(1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF(1) TUBING INSUFFLAT SET W/0 RING ADAPTOR L/F(1) TUBE SUCTION CONNECTING W’ X 12′ LIF(1) TROCAR ENDOPATH XCEL DILATING TIP 5MM(K5LT) LIF(1) CEF AZOLIN RED LABEL(1) GENTAMICIN GREEN LABEL(1) AZUL DE METILENO LABEL(1) HEPARINE WHITE LABEL(1) LIDOCAINE YELLOW LABELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF(2) BANDAGE ELASTIC 6" X 5yrd. LIF(1) U-DRAPE 60" X 70" WITH TAPE SPLIT(1) DURAPREP SURGICAL SOLUTION 26m I LIF(1) STOCKINETIE IMPERVIOUS(1) TUBE SUCTION CONNECT. 3/16" X 12′ LIF(1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF(1) BAG SUTURE FLORAL LIF(1) BLADE SURGICAL #11 CARBON STEEL(2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF(1) SYRINGE 30cc SLIP TIP LIF(1) TABLE COVER 44" x 90"(1) MAYO STAND COVER REINFORCED LIF(4) TOWELS ABSORBENT 15" X 20" LIF(5) LAP SPONGES PRE-WASH XRD UF(1) DRAPE SHEET 41 " x 58" SMS UF(1) NEEDLE HYPODERMIC 22G X 1 Y:z(1) NEEDLE HYPODERMIC 18G X 1 Y:z(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF(10) GAUZE SPONGES 4" X 4" 16PL YEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PREMIUM OPHTHALMIC PACK- CUSTOMED-(1) GOWN SMS X-LARGE STD RAGLAN(1) CUP MEDICINE 2oz(1) DRAPE OPHTHAL. WITH POUCH LIF(1 0) SPONGE EYE SPEAR MICRO(1) SHIELD EYE UNIVERSAL(6) COTTON TIP APPLICATION 6" WOOD LIF(1 0) GAUZE SPONGES 4"X 4" 12PL Y(2) TOWELS ABSORBENT 15" x 20" LIF(1) COVER MAYO STAND REINFORCED LIF(1) SYRINGE 1 ML WITHOUT NEEDLE LUER LOCK LIF(1) COVER TABLE REINFORCED 50" x 90" LIF(1) SYRINGE 3cc WITH NEEDLE 21 G X 1 % LIF(1) GOWN LARGE SMS NON REINFORCED TOWEL/WRAPEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY GYN PACK – – (1) BLADE SURGICAL #11 STAINLESS STEEL(4) DRAPE UTILITY WITH TAPE LIF(2) ABSORBENT TOWEL 15" X 20" LIF(1) GOWN IMPERVIOUS REINFORCED LARGE SMS(1) TOWEL CLOTH HUCK BLUE(1) BLADE SURGICAL #15 CARBON STEEL(2) UTILITY BOWL 16oz(1) UTILITY BOWL 32oz(2) LEGGINS WITH 7" CUFF 30" X 42" LIF(1) EMESIS BASIN 10in 700cc(1) DRAPE VIDEO CAMERA 13cm X 244cm LIF(1) MAYO STAND COVER REINFORCED LIF(10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF(2) TUBE SUCTION CONNECT 114" X 12′ LIF(1) TABLE COVER REINFORCED 44" X 78" UF(1) DRAPE LAP. PERINEAL 102" X 97" WITH POUCH(1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAPEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PERY GYN PACK – (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF(2) GOWN LARGE SMS IMPERVIOUS REINFORCED (1) DRAPE UNDERBUTTOCK WITH POUCH(1) UTILITY BOWL 16oz. (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF(1) ROBNEL CATHETER 18FR. (1) DRAPE SHEET 41 " X 58" SMS(2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UTILITY WITH TAPE UFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – MAJOR LAP PACK – (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD(1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz(1) TUBE CONNECT. SUCTION W X 12′ (1) CAUTERY TIP POLISHER(1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE(2) LIGHT SHIELD (1) MAYO STAND COVER REINFORCED(4) ABSORBENT TOWELS 15" X 20" (2) DRAPE SHEET 41" X 58" SMS(2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (2) GOWN XL SMS IMPERV. REINFORCED(1) SUTURE BAG FLORAL (1) TIME OUT BEACON NON WOVEN(5) LAP SPONGE PREWASH 18" X 18" XRD (1) SKIN MARKER W/8/LABEL/TIME OUT/RULEREO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CYSTO TUR PACK- -(1) UTILITY BOWL 32oz LIF(1) SPECIMEN CUP WITH CAP 4oz LIF(1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF(4) ABSORBENT TOWELS 15" X 20" LIF(1) CYSTOSCOPY ‘T’ DRAPE 60" X 87" X 35" SMS STD LIF(2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF(2) LEGGINS WITH 7" CUFF 30" X 42" LIF(1) TABLE COVER REINFORCED 44" X 78" LIF(1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" LIF(1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF(1) TUR Y SET 81 "2.1 M REGULAR CLAM(4) GAUZE SPONGES 4" X 4" 12 PLY XRD L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – ORTHOPEDIC IMPLANT PACK CUSTOMED USA; CODE 900-2903CONTENTS:(1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER(1) BAG SUTURE FLORAL (1) U – DRAPE 60"" X 70"" WITAPE SPLIT 6"" X 21""(1) TUBE SUCTION CONNECT W’ X 12′ UF (2) PAD ABDOMINAL 8"" X 7.5""(1) BAG GLASSINE (1) YANKAUER SUCTION TUBE W/0 VENT LIF (2) LITE GLOVE UF (1) SOLUTION SURGICAL DURAPREP 26ML LIF(2) TABLE COVER REINFORCED 50"" X 90"" LIF (1) BLADE SURGICAL# 10 STAINLESS STEEL(1) MAYO STAND COVER REINFORCED LIF (1) SHEET SPLIT W/ADHES 108"" X 77"" STD SMS L/F (5) TOWELS ABSORBENT 15"" X 20"" UF (1) STOKINETIE IMPERVIOUS 14"" X 48"" LIF(2) DRAPE SHEET 70"" X 100"" LIF (1) *GLOVE# 7′!h SURGEON NEUTRALON LATEX (5) LAP SPONGE PREWASH 18"" X 18"" XRD LIF (1) *GLOVE # 8 SURGEON NEUTRALON LATEX (1) SKIN STAPLE 35 WIDE UF (1) *GLOVE# 8′!h SURGEON NEUTRALON LATEX(1) TRAY MAYO LGE (1) GOWN SURG REINFORCED XL TOWEUWRAP(1) DRAPE TOP W/ADHES 108"" X 50"" STD SMS UF (2) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) BULB SYRINGE 60cc CLEAR (1) CAUTERY PENCYL ROCKER SWITCH UF(1) UTILITY BOWL 16oz LIF (1) BLADE SURGICAL# 20 STAINLESS STEEL (1) UTILITY BOWL QUART 32oz LIF (4) DRAPE UTILITY WITAPE UF(1) DRAPE INCISION 23"" X 17"" UFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Plastic Pack Customed; code 900-2582(1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO STAND COVER REINF LIF (1) TABLE COVER REINF 50" X 90" LIF (4)(1) PVP PAINT 8" STICK SPONGE(2) DRAPESHEET 41X AMED LIF(3) TOWELS ABSORBENT 15 X 20 LIF(2)DRAPE UTILITY Rape LIF(1) BLADE SURGICAL15 S/STEEL (10) GAUZE SPONGE 4 X 4 16 PL Y(20) APPLICATOR COTOIN 6 WOODProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – NEURO SPINE PACKCONTENTS: (1) SUTURE BAG FLORAL LIF(1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77"" x 110"" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF(1) SHEET ‘I"" 60"" X 77"" DRAPE REINF. LIF(2) SPECIMEN CONTAINER 4oz W/LID & LABEL(2) CUP MEDICINE 2oz UF(2) TUBE SUCTION CONNECT v." X 12’ UF (2) SKIN MARKER INK WITH 8 LABEL(20) GAUZE SPONGE 4"" X 4"" 16ply XRD UF(5) SPONGE LAP PREWASH 18""X 18"" XRD UF (2) SYRINGE 20cc W/0 NDL LILOCK ST.LIF(1) YANKAUER SUCT. TUBE W/0 VENT LIF(1) DRAPE INCISE ANTIMICROBIAL 23"" X 17"" LIF (1) POLISHER CAUTERY TIP LIF(2) PENCIL CAUTERY HAND SWITCHING LIF(1) DRAPE T LAPAROTOMY 102"" X 78"" X 121"" STD SMS LIF (1) GOWN SURG REINFORCED LARGE TOWEL WRAP(2) BLADE SURG #15 CARBON STEEL (1) PK.STRIP SURGICAL %"" X 6"" COTTON (1) PK.STRIP SURGICAL Y4"" X 6"" COTTON (10) GAUZE SPONGE 4"" X 4"" 16ply(1) NEEDLE HYPODERMIC 20G X 1 % (1) BASIN WASH ROUND 6qt(4) SHEET DRAPE 42"" X 57"" SMS LIF(2) DERMABOND HV TOPICAL SKIN ADH (1) BOWL UTILITY 32oz.(2) SYRINGE EAR/ULCER 2oz LIF(2) BLADE EXTENDED ELECTRODE(2) SOLUTION SURGICAL DURAPREP 26mL UF (1) ELECTRODE NEEDLE 1in W/TIP PROTECTOR(1) STRIP SURGICAL ‘I""X 6""(2) GOWN XL SMS IMPERV. REINFORCED UF(1) CORD BIPOLAR FIRCEPS(4) TOWEL CLOTH HUCK (WHITE)(2) DRESSING OPSITE POST PO 2%"" x 2"" (2) POUCH INSTRUMENT 7 X 11(1) MAYO TRAY LARGE(1) MAYO STAND COVER REINFORCED UFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Gown Cool Impervious XLGE Breathable Customed; 900-2592:(1) GOWN XL SURGICAL MICROCOOL(1) WRAPPER 24" X 24"(1) TOWELS ABSORBENT 15" X 20" LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ANGIOGRAPHY PACK- -(4) CLOTH HUCK TOWEL BLUE UF(1) TABLE COVER REINFORCED 50" X 90" LIF(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF(2) MEDICINE CUP 2oz. LIF(3) UTILITY BOWL 32oz UF(1) EMESIS BASIN 10 IN 700cc(4) TOWEL CLAMP(3) ABSORBENT TOWELS 15" X 20" LIF(1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK L/F(1) HALSTED MOSQUITO(1) PVP SCRUB 8" STICK SPONGE(1) TRAY PLATFORM LARGE(3) LABELS FOR SKIN MARKERR(1) LABEL FOR MEDICATION SALINE NORMAL BLUE(1) LABEL FOR MEDICATION TRIDIL VIOLETA(1) NEEDLE HYPODERMIC 18G X 1 ‘h(4) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF(1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF(2) UTILITY BOWL 16oz(3) BAND BAG WITH RUBBAND & TAPE LIF(25) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF(1) DRAPE ANGlO 75" X 145"(1) NEEDLE HYPODERMIC 21 G X 1 ‘h LIF(1) SAFETY SCALPEL #11 LIF(1) GOWN STANDARD SMS LARGE VELCRO NECK(2) NEEDLE HYPODERMIC 23G X 1"(1) TRAY ORGANIZER FULL DEEP(1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP(1) LABEL XYLOCAINE FOR MEDICATION YELLOW(1) LABEL CONTRASTE FOR MEDICATION GREEN(1) LABEL FOR MEDICATION INTEGRILIN RED(1) PVP PAINT 8" STICK SPONGEEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Liposuction Pack MRT; code 900-2656; contains:(1) NEEDLE HYPODERMIC 27 X 1 LIF(1) UTILITY BOWL QUART 32oz LIF(1) MAYO STAND COVER REINFORCED LIF(2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF( 1) PVP SCRUB SOLUTION 4oz BOTTLE(20) GAUZE SPONGES 4 X 4 (12) TOWEL CLOTH HUCK (BLUE)(4) TOWEL CLAMP(3) TIP ABSORBENT APPLICATOR STICK SPONGE LIF( 1) SAFETY SCALPEL 15(3) DRAPE SHEET 70 X 100 LIF(2) TOWEL ABSORBENT 15 X 20 LIF(2) TABLE COVER REINFORCED 44 X 78 LIF(1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF(1) DENTURE CUP 8oz WITH LID(2) SYRINGE 10ML W/FIXED M/L DARK GREEN(1) TUBING INFILTRATION PERISTALTIC PUMPS(2) LITE GLOVES L/FProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Bandeja para Debridacion; code 900-2702; contains:(1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y(1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP(1) TOWEL 3 PLY POLY 13 X 18(1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE(1) CHLORASCRUB SWABSTICK 1.6 ML(1) TRAY KUTIER(1) SCALPEL W/HANDLE 20(1 i WRAPPER 24 X 24Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – NEURO PACK- (1)TABLE COVER 44" x 90"(1) GOWN SURGEON REINFORCED X-LARGE TIWRAP(1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS(1) BAG SUTURE FLORAL(1) MAYO STAND COVER REINFORCED LIF(2) TOWELS ABSORBENT 15" X 20" LIF(4) DRAPE UTILITY WITH TAPE LIF(1) U-DRAPE 60" X 70" WITH TAPE SPLIT(1) STOCKINETTE IMPERVIOUS 14" X 48" L/F(1) SHEET SPLIT WITH ADHESIVE 1 08" X 77" STD SMS LIF(1) TOP DRAPE WITH ADHESIVE 1 08" X 50" STD SMS L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – TRAATEK NEURO PACK(4)TOWEL ABSORBENT 15" X 20" LIF( 1) MAYO STAND COVER REINFORCED LIF( 1) CAUTERY TIP POLISHER LIF(8) TOWEL CLOTH HUCK (BLUE)( 1) BULB SYRINGE 60cc LIF( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE(2) LITE GLOVE( 1) TUBE SUCTION CONNECT. Y.." X 12′ LIF( 1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF( 1) DRAPE % ECONOMY 53" X 77" LIF( 1) SHEET SPLIT W/ADHESIVE 77" x 146"(2) GOWN XL SMS IMPERVIOUS REINFORCED LIF(2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF( 1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF( 1) STAPLE SKIN 35 WIDE LIF( 1) TRAY MAYO LARGE(2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF( 1) SOLUTION SURGICAL DURAPREP 26ml LIF( 1) Pk. NEUROPATTIES 0.45MM 10ea/pk( 1) Pk. NEUROPATTIES 0.35MM 10ea/pkProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF(1) NEEDLE HYPODERMIC 18G X 1 % LIF(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF(1) BOWL UTILITY QUART 32oz.(2) SHEET DRAPE 41" X 58" SMS LIF(2) TOWELS ABSORBENT 15" X 20" LIF(1) BANDAGE GAUZE STRETCH 4"(1) NEEDLE HYPODERMIC 25G X 5/8(2) BLADE SURGICAL #15 STAINLESS STEEL(2) TOWEL CLOTH HUCK BLUE LIF(1) PADDING CAST COTTON ROLL 2" X 4yds(1) STOCKINETTE 6" X 48" L/F(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF(4) DRAPE UTILITY LIF(1) GOWN SURG. FABRIC REINFORCED X-LARGE AAMI Ill LIF(1) TIME OUT BEACON NON WOVEN(1) HAND DRAPE ORTHOARTSO 76" X 150"(1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER(1) BAG SUTURE FLORAL L/F(1) GOWN IMPERVIOUS EXTRA REINFORCED LARGEL TOWEL/WRAP L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LAPAROSCOPY COLORECTAL SURGICAL PACKCONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF(3) TOWELS ABSORBENT 15"" X 20"" LIF (2) LEGGINS W/7" CUFF 30"" X 42"" LIF(1) BLADE SURGICAL# 15 STAINLESS STEEL(1) BLADE SURGICAL# 11 STAINLESS STEEL(1) GOWN IMPERV. EXTRA REINF. XLG AAMI Ill LIF(1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF (10) GAUZE SPONGE 4"" X 4"" 16PLY XRD LIF(2) UTILITY BOWL 16oz. LIF(2) PK. STERI STRIP CLOSURE%" X 4"" L/F(1) ACTIFOG WITH FOAM PAD SOLUTION LIF (1) TABLE COVER REINFORCED 50"" X 90"" LIF (1) MAYO STAND COVER REINFORCED LIF (1) NEEDLE ULTRA VERES 120MM LIF(1) STAPLE ARTICULATING ECHEL 60MM LIF (1) RELOAD WHITE 60MM ECHELON L/F(2) CANNULA 5MM XCEL SLEEVES LIF(1) TROCAR 5MM BLADELE W/STAB SLEEVE UF (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF (10) LAP SPONGES PREWASH 18"" X 18"" XRD LIF(1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (2) LITE GLOVE(1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (1) ELECTRODE DUAL DEPRES(1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF(1) BAG SUTURE FLORAL(1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF (1) POLISHER CAUTERY TIP LIF(1) BAG GLASSINE(1) RELOAD BLUE 60MM LIF(1) TIME OUT BEACON NON WOVEN LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LAPAROSCOPY CHOLE SYSTEM PACKMIAMI METROCON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF(1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50"" X 90"" LIF (1) SUTURE BAG FLORAL LIF(10) GAUZE SPONGE 4"" X 4"" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF(1) BLADE SURGICAL #10 STAINLESS STEEL(2) SHEET% 60"" X 77"" DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18"" X 18"" XRD LIF(1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y."" X 12′ LIF (1) BAG GLASSINE PLAIN(1) CAUTERY TIP POLISHER LIF(1) DRAPE LAP. ABDOMINAL WITH POUCH 102"" X 122"" X 78"" LIF (1) PK. STRIP STERI CLOSURE W’ X 4"" LIF(1) SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1) CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1) COUNTER NEEDLE BLADE 30c MAG/FOAM(1) TIME OUT BEACON NON WOVEN LIF(1) GOWN XL SMS IMPERVIOUS REINFORCED LIF(1) GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1) TOWEL ABSORBENT 15"" X 20"" LIF(1) BLADE SURGICAL #11 CARBON STEEL(1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR WITHOUT C IV LIFATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1) ACTIFOG WITH/FOAM PAD SOLUTION LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – NEURO SPINE PACK; CODE 900-2765CONTENTS:(l ) DRAPE INCISION 23"" X 1 7"" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W’ X 6""(I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F(I) SCALPEL W/HANDLE # 10 S/STEEL (I) TUBE SUCTION CONNECT W’ X I 2′ LIF(I) SKIN MARKER W/RULER (2) SPECIMEN CONTAINER4oz W/LID & LABEL (I) SOLUTION SURGICAL DURAPREP 26ML LIF (I) YANKAUER SUCTION TUBE W/0 VENT LIF(I) MAYO TRAY LARGE (2) NEEDLE & BLADE COUNTER lOc MAG/CLEAR (I) DRAPE INCISE ANTIMICROBIAL 23"" X 1 7"" LIF (2) SYRINGE I Occ W/0 NEEDLE LUER LOCK LIF (I) J VAC RESERVOIR 300ML (2) LITE GLOVE LIF(2) CAUTERY TIP POLISHER LIF (2) TABLE COVER BTC 77"" X 110"" HD FULL L/F (20) GAUZE SPONGE 4"" X 4"" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5"" X 20"" LIF( I ) DRAPE T LAPAROTOMY 102"" X 78"" X 1 21"" STD SMS (5) LAP SPONGE PREWASH 18"" X 18"" XRD LIF ( I) SUTURE BAG FLORAL (5) DRAPE ‘l’4 ECONOMY 53"" X 77"" LIF(3) GOWN IMPERVIOUS EXTRA REI NF. LGE T/WRAP (I) UTILITY BOWL 1 6oz LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – TLIF PACK SURGICAL CENTER; CODE 900-2918.CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF (4) TOWELS ABSORBEN 15"" X 20"" LIF(1) TABLE COVER REINFORCED 50"" X 90"" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE% 60"" X 76"" REINFORCED L/F(1) DRAPE CHEST 100"" X 142"" X 72"" LIF(1) FLUORO COVER 30"" X 30"" WITH RUBBBAND LIF (2) LITE GLOVE LIF(2) TUBE SUCTION CONNECT. Y."" X 12′ UF (12) TOWELS CLOTH HUCK BLUE LIF(1) UTILITY BOWL QUART 32oz(10) GAUZE SPONGE 4"" X 4"" 16PLY XRD UF(5) LAP SPONGE PREWASH 18"" X 18"" XRD LIF(1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER LIF (1) STERI STRIP DRAPE LARGE 17"" X 23"" LIF(1) SKIN MARKER WITH RULER UF(9) LABELS FOR SKIN MARKERS 1.25 X Y2 (1) RULER(1) NEEDLE & BLADE COUNTER 20C FOAM/MAG L/F(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BULB SYRINGE 60cc LIF(4) NEEDLE HYPODERMIC 18G X 1Y2 UF(1) NEEDLE HYPODERMIC 22G X 1Y2 LIF(2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE SPINAL 18G X 6"" LONG LENGTH LIF(1) BLADE SURGICAL # 10 CARBON STEEL (1) BLADE SURGICAL # 15 CARBON STEEL(1) TIME OUT BEACON NON WOVEN UF (2) DRESSING TEGADERM 4"" X 4% ""UF (2) MEDICINE CUP 2oz(1) DRAPE IOBAN INCISE 2 ANTIMICROBIAL 23"" X 23"" LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY CHOLE PACK – (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF(2) SHEET DRAPE 42" X 57" SMS(1) TUBE SUCTION CONNECT. %" X12′ LIF(1) SURGICAL BLADE #10 STAINLESS STEEL(1) TABLE COVER REINFORCED 44" X 78" LIF(1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH POUCH(5) LAP SPONGES PREWASH XRD L/F(1) NEEDLE HYPODERMIC 18G X 1 %"(1) MAYO STAND COVER REINFORCED LIF(1) UTILITY BOWL 32oz. L/F(1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF(4) TOWEL ABSORBENT 15" X 20" L/F(1) CONTAINER SPECIMEN 4oz WITH LID & LABEL(1) CLOTH HUCK TOWEL BLUE L/F(1) PVP PAINT 8" STICK SPONGE(4) DRAPE UTILITY WITH TAPE LIF(2) UTILITY BOWL 16oz LIF(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF(1) PVP SCRUB 8" STICK SPONGES(1) CLIPS LIGATING TIT M/L (L T 300)(4) TEGADERM 2 3/8 X 2% L/F(4) GOWN SURG. REINFORCED LARGE TOWEL/WRAPEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CESAREAN PACK – (1) MAYO STAND COVER REINFORCED LIF(5) TOWELS ABSORBENT LIF(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F(3) DRAPE SHEET 41" X 58" SMS LIF(1) BABY BLANKET PRINTED LIF(1) BOWL PLASTIC 80oz WITH LID(1) TUBE SUCTION CONNECT.%" X 12′ LIF(15) LAP SPONGES PREWASH XRD LIF(1) EAR ULCER SYRINGE 2oz. LIF(1) PAD OBSTETRICAL X-LARGE ST. L/F(1) YANKAUER SUCTION TUBE WITHOUT VENT L/F(1) SYRINGE 20cc SITIP LIF(1) FEEDING TUBE 8FR. 15" LONG(1) BABY BEANNIES LIF(1) DRESSING ISLAND 4" X 14"(1) DRAPE C-SECTION WITH POUCH 102" X 121" X 78"(1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP(1) TABLE COVER REINFORCED 50" X 90" L/F(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF(1) SUTURE BAG FLORAL LIF(1) UMBILICAL CORD CLAMP(1) BLADE SURGICAL #20 CARBON STEEL(1) WRAPPER 24" X 24" L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – UROLOGY PACK – (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT.(1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX(1) BAG SUTURE FLORAL (1) GOWN SURG. REINFORCED X-LARGE T/VIJRAP(1) TABLE COVER 44" X 90" UF (2) DRAPE SHEET 42" X 55" SMS UF(1) TUBE SUCTION CONNECT. Y." X 12′ UF (1) MAYO STAND COVER REINFORCED UF(10) GAUZE SPONGE 4" X 4" 16PLY(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED(1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) TUR Y SET TWO LEAD ST. UF(1) DRAPE LITHO 110" X 63" SMS WITH LEGGINSEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – OPHTALMIC PACK – (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz.(2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF(6) COTION TIP APPLICATOR 6" WOOD (1) TABLE COVER REINFORCED 50" X 90" UF(1) PAD EYE 2 1/8 X 2 5/8 (1) CYSTOTOMO IRRIG. PEARCE 25G X 5/8(1) SHIELD EYE UNIVERSAL (1) Pr. GLOVES SURG.# 7% LATEX(10) SPONGE EYE SPEAR MICRO (1) SYRINGE 1cc TUBER. 25G X 5/8 SITIP UF(10) GAUZE SPONGES 4" X 4" 12PL Y (1) Pr. GLOVES SURG. 8 POWDER LATEX(1) MAYO STAND COVER REINFORCED UF (1) BLADE 15D WITH HANDLE (STABKNIFE)(1) EYE DRAPE (1) GOWN LARGE STANDARD SMS(1) TRAY 3/COMPART (1) BAG ZIP LOCK(1) ANGLED FULL HANDLE (1 ) Pr. GLOVES SURGICAL# 6% LATEXEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90"(1) PRE PAD WITH CUFF(2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill(1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP(1) MAYO STAND COVER REINFORCED(1) TUBE SUCTION CONNECT. X" X 12′(1) STOCKINETTE IMPERVIOUS 14" X 48"(1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" x 21 "(1) SHEET ARTRHOSCOPY "T" W/POUCH STD SMS(1) SUTURE BAG FLORAL(3) ABSORBENT TOWEL 15" X 20"EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – HIP ORTHOPEDIA PACK – (1) BLADE SURGICAL #15 STAINLES /STEEL(1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF(1) TABLE COVER REINFORCED 50" X 90" LIF(1) MAYO STAND COVER REINFORCED LIF(4) DRAPE UTILITY WIT APE LIF(4) TOWEL ABSORBENT 15" X 20" LIF(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF(2) DRAPE SHEET 41" X 58" SMS LIF(1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF(10) GAUZE 4" X 4" 4PLY(2) UTILITY BOWL 16oz LIF(1) CAUTERY TIP POLISHER LIF(1) SUTURE BAG FLORAL(1) BLADE SURGICAL#10 STAILESS STEEL(1) SURGICAL DURAPREP SOLUTION 26m! LIF(1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL(10)GAUZE SPONGE 4" X 4" 16PLY XRD LIF(5) LAP SPONGE PRE WASH 18" X 18" XRD LIF(1) CAUTERY PENCIL ROCKER SWITCH LIF(1) TUBE SUCTION CONNECT. 3/16" X 12′ LIF(1) DRAPE INCISE ANTIMICROBIAL 23" X 33"(2) SHEET DRAPE 70" X 100" LIF(1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF(1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ENDOVENOUS CUSTOM PACK – CUSTOMED(1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F(1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF(2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF(20) GAUZE SPONGE 4" X 4" 12PL Y LIF(3) GOWN SMS X-LARGE STD NON REINFORCED( 1) TABLE COVER 44" X 90"(4) DRAPE UTILITY WITH TAPE L/F( 1) DENTURE CUP WITH LID( 1) UTILITY BOWL 16oz.(2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR L/F(4) RUBBER BAND( 1) NEEDLE HYPODERMIC 27G X 1 Y.."( 1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF(3) CAP NURSE 21 " GREEN BOUFFANT(3) MASK SURGICAL BLUE 120MM HG LIF( 1) PREPPING PAD WITH CUFF(2) TIP ABSORB. APPLIC. STICK SPONGE L/F( 1) SCALPEL WEIGHTED SAFETY # 11( 1) PROBE DRAPE ST 6" X 96" NO GEL LIF( 1) WRAPPER 30" X 30"(3) TOWELS ABSORBENT 15" X 20" L/FProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LABOR & DELIVERY PAC – 1) NEEDLE HYPODERMIC 18G X 1% ST.(2) DRAPE UNDERBUTTOCK WITH POUCH(4) TOWELS ABSORBENT 15" X 20"( 1) FEEDING TUBE 8FR; 15" LONG( 1) BEANNIES BABY( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK( 1) UMBILICAL CORD CLAMP ST.( 1) RECEIVING BLANKET 100% COTTON( 1) TOWELS CLOTH HUCK (BLUE)(2) LEGGINGS W/7" CUFF 30" X 42"( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV.( 1) BOWL PLASTIC 80oz( 1) LID FOR BOWL 80oz CLEAR(20) GAUZE SPONGE 4" X 4" 16PLY(2) PAD OBSTETRICAL X-LARGE ST.( 1) PACKING VAGINAL XRD 4 X 36 8PLY( 1) TABLE COVER REINFORCED 50" X 90"( 1) DRAPE ABDOMINAL WITH TAPE 40" X 54"(1 ) NEEDLE HYPODERMIC 21G X 1% ST.(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK(2) PVP SCRUB 8" STICK SPONGES ST.( 1) EAR ULCER SYRINGE 2oz.( 1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED(2) WRAPPER 30" X 30"( 1) PVP PAINT 8" STICK SPONGE ST.(2) GLOVE SURG DERMA PRENE #7 % PF(1) TIME OUT BEACON NON WOVEN ST.(1) VACUTAINER GREEN NAHEP 10MLEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – CYSTOSCOPY PACK Ill (1) (2)CUSTOMEDCONTENTS: (1) TABLE COVER REINFORCED 44"" X 78"" (2) TOWELS ABSORBENT 15"" X 20""(2) LEGGINGS W/7"" CUFF 30"" X 42""(1) DRAPE CYSTOSCOPY T 60"" X 87"" 35"" SMS STD(1) GOWN SURG.REINFORCED XL EXTRA LONG LEVEL IVProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Universal Pack II (2) Customed 900-2509(1) MAYO STAND COVER REINFORCED(2) DRAPE SIDE 42" X 76" WITH TAPE(1) DRAPE BOTTOM ABSORBENT REINFORCED 71" X 62" STD SMS WITH TAPE(1) DRAPE TOP W/ADHESIVE 1 08" X 50" STD SMS(1) SUTURE BAG FLORAL(1) TABLE COVER REINFORCED 50" X 90"(1) GOWN SURG. REINFORCED XLGE TOWEL I WRAPProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Shoulder pack (I) (2); code 900-2515(1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill(1) TOWEL ABSORBENT 15" X 20"(1) GOWN XXL SMS IMPERVIOUS REINFORCED(1) MAYO STAND COVER REINFORCED(2) STRIPS TAPE 24" X 4"(1) SUTURE BAG FLORAL(1) SHEET SPLIT W/ADHESIVE 1 08" X 77" STD SMS(1) DRAPE SHOULDER SPLIT W/ADHESIVE(1) TABLE COVER REINFORCED 50" X 90"Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAMINECTOMY PACK -( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF( I) TUBE SUCTION CONNECT. W’ X 12′ LIF (6) DRAPE UTILITY W/TAPE LIF(I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (2) UTILITY BOWL 16oz. LIF( IO) LAP SPONGE PRE-WASH XRD LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL(2) MAYO STAND COVER REINFORCED LIF ( I) GOWN SURG. REINF. XL TOWEL WRAP(6) ABSORBENT TOWEL I5" X 20" LIF ( I) DRAPE LAP 102" X 121" X 78" W/POUCI-1 SMS LIF( I) SURGICAL DURAPREP SOLUTION 26ML LIF (6) DRAPE SHEET 41" X 69" MEDIUM LIF(2) LEGGING W/7" CUFF 30" X 42" LIF (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR( I) CAUTERY PENCIL PUSH BOTTOM LIF ( I) BAG SUTURE FLORAL LIF( I) PVP SCRUB 8" STICK SPONGE ( I) MAYO TRAY LARGE LIF(I 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF ( I) SURGICAL BLADE# I 0 CARBON STEEL(2) BULB SYRINGE 60cc CLEAR LIF ( I) SURGICAL BLADE# I I CARBON STEEL( I) SURGICAL BLADE # 15 CARBON STEEL ( I) GOWN FABRIC REINFORCED SONTARA XL LIF( I) SYRINGE IOcc W/NDL 20G X I Y; LILOCK LIF( I) PVP PAINT 8" STICK SPONGE( I) SURGICAL STRIP W’ X 6" COTTON (2) LITE GLOVES LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ANGIODRAPE PACK – -(1) GUIDEWIRE 0.035" X 150cm(2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF(2) Pr. SURGICAL GLOVES #8(2) GOWN STANDARD LARGE SMS VELCRO NECK(2) NEEDLE HYPODERMIC 21G X 1 W’ UF(1) TABLE COVER 44" X 90"(3) CLOTH HUCK TOWELS BLUE(2) UTILITY BOWL 16oz L/F(1) SOLUTION SURGICAL DURAPREP 26ML UF(3) DRAPE UTILITY WITH TAPE UF(3) TOWEL CLAMP(2) TOWELS ABSORBENT 15" X 20" UF(1) NEEDLE 18G X 2% AMC/4(1) FEMORAL ANGlO DRAPE WITH POUCH UF(1) BAND BAG RUBBAND & TAPE UF(1) CUP DENTURE WITH LID(30) GAUZE SPONGE 4" X 4" 12PL Y(2) TIP ASBORBENT APPLICATOR STICK SPONGE(1) SCALPEL WITH HANDLE #11(1) STOPCOCK 3 WAY(1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F(1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Face Lift ; Code 900-3083; contains:(I) SHEET ENT SPLIT 110" X 77" LIF(I) COVER TABLE REINFORCED 50" X 90" LIF(I) DRAPE HEAD WITH TAPE 44" X 26" LIF(I) COVER MAYO STAND REINFORCED LIF(I) BAG SUTURE FLORAL LIF(3) GOWN STANDARD LARGE SMS VEL/NELABEL SAMPLE(I) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF( I) STAPLE SKIN 35 WIDE LIF( I) TUBE SUCTION CONNECT W’ X 12′ L/F( I) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF(2) BLADE # I5 CARBON RIB( I) NEEDLE SPINAL ANEST22G X 3\12 LIF( I) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE 8.0 POWDER FREE LIF(2) *PR. GLOVE SURG. 6.5 POWDER LATEX(I) GUT PL FAST ABSORB 5-0(2) SUTURE 2.0 VICRYL 25MM(3) TOWELS ABSORBENT 15" X 20" LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – FOLEY CATHETER KIT 1116FR. – CUSTOM ED-(1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR(2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM(1) TOWEL 3PLY POLY 17" X 18" (2) SWABSTICK DRY COTTON(1) DRAPE 4" FENESTRATED 18" X 26" (1) CATHETER 16FR. FOLEY; 2 WAY;5cc; Silicone Coated(1) SYRINGE 10cc WATERPREFIL UF (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF(1) LABEL ID PATIENT (1) TRAY ORGANIZER(1) SPECIMEN CONTAINER 4oz. W/LID & LABELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PERY GYN PACK – (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY(2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill(1) DRAPE UNDERBUTIOCK W/POUCH 44" X 35" (1) TIME OUT BEACON NON WOVEN(1) BOWL UTILITY BLUE 16oz (1) BAG SUTURE FLORAL(1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) GOWN IMPERV. EXTRA REINF LGE AAMI LEVEL Ill T/WRAP(1) CATHETER 16" 18FR MALE PVC (2) LEGGINS W/7" CUFF 30" X 44"EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK – – (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP(1) BLADE SURGICAL #11 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN UF(10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN XLARGE SMS IMPERV. REINFORCED(3) TOWEL ABSORBENT 15" X 20" UF (1) TUBBING INSUFFLATION SET WITHOUT RING(1) MAYO STAND COVER REINFORCED UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG UF(1) TABLE COVER REINFORCED 50" X 90" UF (1) SKIN MARKER INKW/8LABEUTIME OUT/RULER(1) DRAPE SHEET 41 " X 58" SMS UF (1) BAG SUTURE FLORAL(4) DRAPE UTILITY UF (1) TUR CYSTO IRRIGATION SET 79" SINGLE UF(1) TUBE SUCTION CONNECT. 3/16 " x 12′ UFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ANGIOGRAPHY PACK – ( 1) FEMORAL ANGlO. DRAPE WITH POUCH(2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF(2) NEEDLE HYPODERMIC 21G X 1%( 1) TABLE COVER REINFORCED 44" X 78" LIF(30) GAUZE SPONGES 4" X 4" 12PLY( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS( 1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP( 1) GUIDEWIRE .035" X 150cm MOVABLE(2) BAND BAG RUBBAND & TAPE L/F(2) DENTURE CUP 8oz. WITH LID( 1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF( 1) NEEDLE HYPODERMIC 18G X 1 %( 1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F(4) DRAPE UTILITY WITH TAPE L/F(2) SOLUTION SURGICAL DURAREP 6ml L/F(2) TOWEL CLAMP(1) NEEDLE 18G X 2% AMC/4(4) TOWELS CLOTH HUCK BLUE( 1) UTILITY BOWL 16oz. LIF( 1) SCALPEL WITH HANDLE # 11EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Tummy Tuck Pack-BOD ; code 900-3026; contains:(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII(2) TOWELS ABSORBENT 15 X 20(1) PENCIL CAUTERY PUSH BOTTOM(1) COUNTER NEEDLE/BLADE 20C FOAM/MAG(1) BOWL UTILITY QUART 32oz TURQ(1) COVER MAYO STAND REINFORCED(2) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER(1) COVER TABLE REINFORCED 50 X 90(1) CUP DENTURE 8oz TEAL WITH LID(1) RULER ACCU-6(6) TOWELS CLOTH HUCK C BLUE(1) TUBE SUCTION CONNECT (1) DRAPE BREAST/CHEST(2) LITE GLOVEProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – FANFOLD DRAPE – CUSTOMED(1) DRAPE SHEET 42" X 57" SMS(1) WRAPPER 24" X 24"EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ARTHROSCOPY PACK – (1) MAYO STAND COVER REINFORCED LIF(1 0) GAUZE SPONGES 4" X 4" 16PL Y(1) TUBE SUCTION CONNECTING X" X 12′ LIF(1) IMP. STOCKINETTE(1) SURGICAL BLADE #11 STAINLESS STEEL(1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~(1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUER LOCK LIF(2) ELASTIC BANDAGE 6" X 5yrd LIF(1) TUR Y SET 81 "2.1m REGULAR CLAM(2) NEEDLE HYPODERMIC 18G X 1 ~(1) TABLE COVER 50" X 90" REINFORCED LIF(5) TOWEL ABSORBENT 15" X 20" LIF(2) DRAPE UTILITY WITH TAPE LIF(1) DURAPREP SURGICAL SOLUTION 26m I LIF(1) U-DRAPE 60" X 70" WITH TAPE SPLIT(1) Pr. NEUTRALON SURGEON GLOVES #7.5(1) Pr. NEUTRALON SURGEON GLOVES #8(1) Pr. NEUTRALON SURGEON GLOVES #8.5(2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS(10) GAUZE SPONGES 4" X 4" 16PLY XRD(2) STRIPS TAPE(1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF(1) DRAPE VIDEO CAMERA LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CESAREAN PACK- – (3) ABSORBENT TOWELS 15" x 20" LIF(1) PLASTIC BOWL WITH LID 80oz.(1 0) LAP SPONGES PRE-WASH 18" x 18" XRD(2) PAD OBSTETRICAL X-LARGE ST.(1) MAYO STAND COVER REINFORCED LIF(1) DRAPE SHEET 41" x 58" SMS LIF(2) TUBE SUCTION CONNECT. Y.." X 12′ LIF(1) EAR ULCER SYRINGE 2oz. LIF(1) YANKAUER SUCTION TUBE WITHOUT VENT L/F(1) UMBILICAL CORD CLAMP(1) SURGICAL BLADE #20 CARBON STEEL(1) TABLE COVER REINFORCED 50" X 90" LIF(1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF(1) DRESSING ISLAND 4" X 1 0"(1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78"(1) BABY BLANKET PRINTED(1) GOWN IMPERVIOUS REINFORCED LARGE SMS(1) BAG SUTURE FLORALEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Drape Sheet; Product Code 2942; contains(1) DRAPE % ECONOMY 53 X 77L/F(1) WRAPPER 24 X 24 L/FProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – BASIC PACK IV (6) CUSTOMEDCONTENTS: (3) TOWELS ABSORBENT 15"" X 20""(1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53"" X 77""(1) DRAPE SHEET 41"" X 58"" SMS(4) UTILITY DRAPE W/TAPE (1) SUTURE BAG FLORAL(1) TABLE COVER REINFORCED 44"" X 78""(2) GOWN SOFT SMS STD; XLGE SET IN SLEEVEProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ARHTROSCOPY PACK- (1) U-DRAPE 60" X 70" WITH TAPE SPLIT(1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE(1) TOWEL ABSORBENT 15" X 20"(1) MAYO STAND COVER REINFORCED(1) TABLE COVER REINFORCED 50" X 90"(1) BAG SUTURE FLORAL(1) STOCKINETTE IMPERVIOUS 14" X 48"(4) STRIPS TAPE 24" X 4"(1) SHEET EXTREMITY ABS. 125" X 85"(1) TIME OUT BEACON NON WOVEN ST.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAP Abdom w/pouch Customed code 900-2619; contains:(1) DRAPE LAP. ABDOM W/POUCH 102" X 122" X 78"(1) WRAPPER 30" X 30"Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROTOMY PACK – CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF( 1) MAYO STAND COVER REINFORCED LIF(1) BAG SUTURE FLORAL LIF(4) DRAPE UTILITY WITH TAPE LIF(2) DRAPE SHEET 41 II X 58" SMS L/F( 1) TABLE COVER 50" X 90" LIF( 1) SOLUTION SURGICAL DURAPREP 26ML LIF(1) BLADE SURGICAL# 10 CARBON STEEL(5) LAP SPONGE PREWASH 18" X 18′ XRD LIF(6) TOWELS ABSORBENT 15" X 20" LIF( 1) CAUTERY TIP POLISHER L/F(2) UTILITY BOWL 16oz LIF(1) TUBE SUCTION CONNECT%" X 12′ LIF(2) NEEDLE & BLADE COUNTER 10c MAG /CLEAR LIF(1) DRAPE T LAPAROTOMY 102" X 78" 121" SMS STD LIF( 1) SPECIMEN CONTAINER 4oz WITH LID & LABEL( 1) YANKAUER SUCTION TUBE WITHOUT VENT LIF( 1) TIME OUT BEACON NON WOVEN LIF( 1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LAPAROSCOPY ABO PACK (1) (2)CUSTOMEDCONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15"" X 20""(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED(1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITH TAPE(1) SUTURE BAG FLORAL(1) DRAPE LAPAROSCOPY CHOLE W/TROU (1) TABLE COVER REINFORCED 50"" X 90""Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – TRANSVERSE LAPAROTOMY PACK (8)CUSTOMEDCONTENT: (1) TOWEL ABSORBENT 15"" X 20""(1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE(1) SUTURE BAG FLORAL(1) DRAPE LAP TRANSVERSE(1) TABLE COVER REINFORCED 50"" X 90""(1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP (1) GOWN XL SMS IMPERVIOUS REINFORCEDProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – ANGIOGRAPHY PACKCONTENTS: (4) CLOTH HUCK TOWEL BLUE(1) TABLE COVER REINFORCED 50"" x 90"" LIF(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF(2) UTILITY BOWL 32oz LIF(1) EMESIS BASIN 101N 700cc(4) TOWEL CLAMP(3) TOWELS ABSORBENT 15"" x 20"" LIF(1) MOSQUITO HALSTED(2) CHLORASCRUB SWABSTICK 5.1ML (1) PLATFORM TRAY LARGE(1) SCALPEL SAFETY #11(3) LABELS FOR SKIN MARKER(1) LABEL F/MED. SALINE NORMAL BLUE (1) NEEDLE HYPODERMIC 18G X 1 Y2(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 16oz(4) BAND BAG WITH RUBBAND & TAPE LIF(20) GAUZE SPONGE 4"" X 4"" 16PLY XRD LIF(1) FEMORAL ANGIOGRAPHY DRAPE WITH POUCH(1) NEEDLE HYPODERMIC 21G X 1 Y2 (1) GOWN STANDARD SMS LARGE(2) NEEDLE HYPODERMIC 23GA X 1""(1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) LABEL FOR MEDICATION TRIDIL VIOLETA(1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) WASH BASIN ROUND 6QT.Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – 0.B. PACK – HSCH- (1) PVP SCRUB 8" STICK SPONGES(1) UNDERBUTTOCK DRAPE WITH POUCH(2) LEGGINS WITH 7" CUFF 30" X 42"(1) ABDOMINAL DRAPE WITH TAPE LIF(1) SPONGE LAP PREWASH 18" X 18" XRD LIF(1) BOWL PLASTIC WITH LID 80oz LIF(1) RECEIVING BLANKET 100% COTTON(1) BABY BLANKET IMPERVIOUS POLY ABS. LIF(1) UMBILICAL CORD CLAMP(3) ABSORBENT TOWELS 15" X 20" LIF(1) UTILITY BOWL 16oz LIF(2) TRAY ORGANIZER FULL DEEP(3) ABSORBENT TIP APPLICATOR(2) GLOVE EXAM MEDIUM(1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP(10) GAUZE SPONGE 4" X 4" 12PLY(2) PAD OBSTETRICAL X-LARGE ST. LIF(1) EAR ULCER SYRINGE 2oz UF(1) BABY BEANNIES(2) DRAPE SHEET 41 " X 58" SMS(1) SCISSORS UMBILICAL(1) TABLE COVER REINFORCED 44" X 78" L/F(2) WRAPPER 24" X 24" LIEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROTOMY PACK – (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz(I) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR( I) DRAPE T LAPAROTOMY STD SMS (2) TOWELS ABSORBENT 15" x 20"(2) GOWN IMP. REINFORCED LARGE SMS (4) DRAPE UTILITY WITH TAPE( I) TABLE COVER REINFORCED 50" X 90" ( I) MAYO STAND COVER REINFORCED( I) ELECTRODE DUAL DEPRES./GROUNDPAD ( I ) CAUTERY PENCIL ROCKER SWITCH(2) DRAPE SHEET 42" X 55" SMSEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – SHOULDER PACKCODE 900-2766CONTENTS: (1) STAPLE SKIN 35 WIDE LIF(1) *GOBAN SELF-ADH 4"" X 5YD WRAP TAN LATEX (2) U-DRAPE 60"" X 70"" WITAPE SPLIT 6"" X 21""(1) TABLE COVER 44"" X 90""(4) TOWELS ABSORBENT 15"" X 20"" LIF(2) TUBE SUCTION CONNECT"" X 12′ LIF(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL(1) SYRINGE 20cc W/0 NEEDLE LUER/LOCK LIF (1) SCALPEL WEIGHTED SAFETY #11(1) NEEDLE SPINAL ANESTH 18G X 3% LIF(1) DRAPE INCISE ANTIMICROBIAL 23"" X 17"" LIF (1) CHLORAPREP 26ML APLICATOR TEAL LIF(2) ATTACHABLE POUCH BEACH CHAIR 35"" X 43"" WITH SUCTION PART (4) DRAPE UTILITY WITAPE L/F(4) STERI-DRAPE SMALL TOWEL DRAPE NPN-STERILE 17"" X 11"" LIF (1) BOWL UTILITY 32oz.(1) STOCKINETTE 6"" X 48"" L/F(5) LAP SPONGE PREWASH 18"" X 18"" XRD LIF (1) WRAPPER 24"" X 24""(1) NEEDLE HYPODERMIC 22G X 1 %(1) GOWN SURG REINFORCED X-LARGE TOWEL I WRAP (1) GOWN MICROCOOL IMPERV. EXTRA LONG X-LARGE (2) DRAPE ORTHOPEDIC SPLIT(1) MAYO STAND COVER REINFORCED LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF(2) ABSORBENT TOWELS 15" X 20" UF(1) MAYO STAND COVER REINFORCED UF(4) BANDAGE ADHESIVE W’ x 3" L I F(4) DRAPE UTILITY WIT APE UF(1) TUBE SUCTION CONNECT. Y.." X 12′ UF(1) INSUFLAT TUBING SET W/0 RING ADAPTOR UF(1) LAPAROSCOPY ABO. DRAPE W/Pouch UF(1) IMP. GOWN REINFORCED XLge. SMS(2) SYRINGE 60ML W/0 NDL. LILOCK UF(1) SYRNGE 20 cc W/0 NDL ULOCK UF(1) SURGICAL BLADE #15 C/STEEL(1) DRAPE LASER CAMERA W/EL(2) COVER HANDLE LITE LOCK(1) TABLE COVER Reinforced 50" x 90" UF(3) DRAPE SHEET 41 " x 58" SMS(1) SURG. GOWN REINFORCED T/Wrap Lge.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – O.B. PACK – (I) TABLE COVER REINFORCED 50" X 90" LIF(I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35"(2) LEGGINS W/7" CUFF 30" X 42"(1) GOWN LARGE SMS IMPERVIOUS REINFORCED(3) TOWELS ABSORBENT 15" X 20" LIF(I) PAD OBSTETRICAL X-LARGE ST.(I) PACKING VAG JNAL 4" X 36" 8PL Y XRD(10) GAUZE SPONGES 4" X 4" 12PLY XRD(I) UMBILICAL CORD CLAMP(1) BABY BLANKET PRINTED(2) EAR/ULCER SYRINGE 2oz. LIF(I) COVER SET UP 42" X 75" CLEARPOLY(1) DRAPE ABDOMINAL WITH TAPE L/F(1) BOWL WITH LID PLASTICS 80oz. L/F(1) SHEET DRAPE 41" X 58" SMS LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY PREMIUM PACK – (1) TABLE COVER REINFORCED 50" x 90" UF(4) TOWEL ABSORBENT 15" x 20" UF(10) GAUZE SPONGE 4" X 4" 16PLY XRD UF(1) DRAPE LASER CAMERA W/EL UF(1) TROCAR ENDO.XCEL DILATING TIP (KSLT)(1) APPLIER CLIP 5MM(3) GOWN XLGE SMS IMPERV. REINFORCED(1) BLADE SURGICAL #11 S/STEEL(1) NEEDLE PNEUMO INSUFLAT. 150MM UL UF(1) MAYO STAND COVER REINFORCED UF(1) DRAPE LAPAROSCOPY ABDOM. W/POUCH(4) DRAPE UTILITY WITH TAPE UF(1) TUBING INSUFFLATION SET W/0 RING ADAPTOR U/F(1) TROCAR DILATING XCEL 5MM x 100 (D5LT)(1) TROCAR ENDO.XCEL DILATING TIP 11MM(1) SUTURE BAG FLORAL UF(1) CLOSURE SKIN W’ X 4" STERI STRIP LFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PERl GYN PACK -(1) TOWEL NON ABS. W/TAPE L/Free(1) DRAPE UNDERBUTTOCK W/POUCH(2) TOWELS ABSORBENT L/Free(2) LEGGINGS W/7" CUFF(1) DRAPE TOP WI ADHESIVE(1) TABLE COVER REINF. L/Free(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF(1) CATHETER 14FR ROBIN NELAT PVC(2) GOWN LGE SMS IMPERVIOUS REINF.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – CERVICAL PACKADVANCED AMBULATORY SURGICAL CENTERCONTENTS: (1) COVER TABLE REINFORCED 50"" X 90"" (1) COVER FLUORO 30"" X 30"" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60"" X 77"" DRAPE REINFORCED(10) GAUZE SPONGE 4"" X 4"" 16PLY XRD (1) SKIN MARKER W/RULER(1) DRAPE THYROID 100"" X 142"" X 72"" (1) TAPE TEGADERM 2-3/8 X 2-3/4(1) SOLUTION SURGICAL DURAPREP 6ML (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) NEEDLE 30G X 1 DISP (2) GAUZE SPONGE 2"" X 2"" 4PLY NON WOVEN(1) STRIP STERI CLOSURE %" X 4"" (2) GOWN SOFT SMS STD XL SET IN SLEEVE (4) NEEDLE HYPODERMIC 18G X 1 % (1) RULER FLEXIBLE PLASTIC(4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK (1) BAG ZIP LOCK(1) STRIP STERI DRAPE LARGE 17"" X 23"" (9) LABELS FOR SKIN MARKERSProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LAPAROSCOPY PACKCONTENTS:( I ) BULB SYRINGE 60cc LIF( I 0) GAUZE SPONGE 4"" X 4"" 1 6PLY XRD LIF( I ) MAYO STAND COYER REINFORCED LIF( I ) TABLE COVER REINFORCED 50"" X 90"" LIF(3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5"" X 20"" LIF( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF (3) LITE G LOVE LIF( I ) DRAPE LAP ABDOM. WI POUCH 102"" X 122"" X 78"" ( I ) BLADE SURG ICA L # II STAIN LESS STEEL( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF( I ) SUTURE BAG FLORAL(I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1′ ( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF (2) DRESSING NON ADH TELfoA 4 X 3( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL (2) SH EET ‘ll.o 60"" X 77"" DRAPE R EI NFORCED LIF( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF ( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF( I ) WRAPPER 24"" X 24""(2) DENTURE CUP 8oz WILIDADHERED OUTSIDE OF THE PACK INTO A POUCH: ( I ) NEEDLE ULTRA VERES 1 20MM LIF( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT)( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT)( I ) CANNU LA 5MM XCEL SLEEVES LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Hair Restoration Pack- ; code 900-2966; contains:(1) MAYO STAND COVER 23X54(2) TOWEL CLOTH HUCK BLUE(2) TABLE COVER BACK ZONE REINFORCED 44 X 90(2) GOWN SOFT SMS STD. X-LARGE AAMI Ill(2) TOWEL ABSORBENT 15 X 20(1) MINDE KNIFE 1.0MM; WIDE; 40 DEGREE ANGLE; 6.0MM IN LENGTHProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Breast Implant Pack; Code 900-2660; contains:(1) DRAPE ECONOMY 53 X 77(3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE(3) TOWELS ABSORBENT 15 X 20(1) MAYO STAND COVER REINFORCED(2) TABLE COVER REINFORCED 50 X 90(1) SUTURE BAG FLORAL(1) TUBE SUCTION CONNECT Y(6) TOWEL CLOTH HUCK BLUE(4) PAD ABDOMINAL 8 X 7.5(2) LITE GLOVES(1) CAUTERY TIP POLISHER LIF(1) BLADE SURGICAL CARBON STEEL 15(1) YANKAUER SUCTION TUBE W/0 VENT(1 0) LAP SPONGE PREWASH 18 X 18 XRD(1) CAUTERY PENCIL ROCKER SWITCH W/HOLSTER(1) UNDERPAD 23 X 36Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LIPOSUCTION PACK AESTHETIC SURG.CENTERCONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18"" X 18"" XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX(1) TABLE COVER REINF 50"" X 90"" LIF (2) GOWN SOFT SMS STD XL SET IN SLEEVE L/F (4) DRAPE SHEET 44"" X 58"" SMS LIF (1) TRAY ORGANIZER FULL DEEP(3) SHEET% 53"" X 77"" REINF. LIF (2) TOWELS ABSORBENT 15"" X 20"" LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – VAGINAL PROCEDURE PACKCUSTOM EDCONTENTS: (1) DRAPE LITHOTOMY 110"" X 63"" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF(1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL(1) COVER TABLE REINF 50"" X 90"" LIF(1) TUBE SUCTION CONNECT. W’ X 12′ LIF (1) GOWN SURG REINF XL T/WRAP(20) GAUZE SPONGE 4"" X 4"" 16 PLY XRD LIF (1) PENCIL CAUTERY HAND SWITCHING(1) PVP PAINT 8"" STICK SPONGE(1) PVP SCRUB 8"" STICK SPONGE(1) SYRINGE 20cc W/0 NDL LUER LOCK LIF (1) TOWEL ABSORBENT 15"" X 20"" LIF(1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) PRE PAD WITH CUFF(1) PACKING VAGINAL XRD 4"" X 36"" 8PLY (2) PAD OBSTETRICAL XL(1) CATHETER 2/W 16Fr. PRESS W/UBAG 2000ML (1) TIME OUT BEACON NON WOVEN LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15"" X 20"" LIF (2) DRAPE SHEET 42"" X 57"" SMS LIF(1) SAFETY IV INTROCAN 18 X 1X ST. LIF(2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF (2) VESSEL LOOP SURGICAL MAXI BLUE(1) SUTURE AID BOOT STD YELLOW ST. LIF(1) YANKAUER SUCTION TUBE WITHOUT VENT L/F(1) EMESIS BASIN 101N 700cc LIF (2) LIGHT SHIELD(1) NEEDLE HYPODERMIC 18G X 1 L/F (1) CATHETER IV SAFETY 20G X 1X LIF(1) DRAPE T LAPAROT 102"" X 78"" X 121"" SMS STD LIF (10) LAP SPONGE PREWASH 18"" X 18"" XRD LIF(1) MAYO STAND COVER REINFORCED LIF (1) STOCKINETTE IMPERVIOUS 14"" X 48"" LIF(2) SYRINGE 20cc WITHOUT NEEDLE LUER I LOCK LIF (1) SUTURE BAG FLORAL LIF(2) UTILITY BOWL 16oz. L/F(1) CAUTERY TIP POLISHER LIF(1) TABLE COVER REINFORCED 50"" X 90"" LIF (4) DRAPE UTILITY WITH TAPE LIF(1) MAYO TRAY SMALL(1) SCALPEL SAFETY WEIGHTED #15 (1) SCALPEL SAFETY WEIGHTED #11(2) TUBE SUCTION CONNECT X"" x 12′ LIF(2) NEEDLE & BLADE COUNTER; 1Oc MAG/CLEAR LIF (1) TIME OUT BEACON NON WOVEN ST. LIF(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER L/FProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Extremity Pack; code 900-2615; contains:(5) LAP SPONGE PREWASH 18" X 18" XRD(1) ELASTIC BANDAGE WITH VELCRO 4 X 5(2) BLADE SURGICAL# 15 STAINLES STEEL(4) DRAPE UTILITY WITH TAPE(1) GOWN XL SMS IMPERVIOUS REINFORCED( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP(1) SKIN MARKER WITH RULER(1) TUBE SUCTION CONNECT Y4" X 12′( 1) CAST PADDING SOFT ROLL 4" X 4yds(10) GAUZE SPONGE 4" X 4" 16PLY( 1) MERLING SKIN PREP APPLIC 39ML(1) MAYO STAND COVER REINFORCED( 1) TABLE COVER REINFORCED 50" X 90"(2) DRAPE SHEET 42" X 55"( 1) STOCKINETTE 9" x 48"(1) CAUTERY PENCIL ROCKER SWITCH(2) LITE GLOVE( 1) BANDAGE ESMARK 6" X 9yds( 1) SHEET EXTREMITY ABS SMS 125" X 85"( 1) UTILITY BOWL QUART 32ozProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – EAR PACK CONTENTS:(I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc(2) LABEL FOR SKIN MARKERS( I) NEEDLE HYPODERMIC 1 80 X I Y;( I) WASI-l BASIN ROUND 6QT(I) INSTRUMENT POUCH 7 X I I 2 COMPART(I) STRIP STER I CLOSURE W’ X 4"" LIF(I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF( I) SH EET ENT SPLIT 11 0 X 77(2) LITE GLOVE(2) NEEDLE H YPODERM IC 27G X I \!.."(1 2) TOWELS CLOTH HUCK (BLUE)( I ) TUBE SUCTION CONNECT.’!."" X 12′ L/F ( I ) EAR ULCER SYRINGE 2oz LIF( I ) TABLE COYER REINFORCED 50"" X 90"" LIF ( I ) UTILITY BOWL 1 6oz LIF(4) COTrON APPLICATOR 6"" WOOD( I ) INSTRUMENT WIPE I MM 8.25 X 8.25( I ) MAYO STAND COYER REINFORCED LIF( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF ( I ) TRAY MAYO SMALL( I ) SYRING E IOcc TI P CONTROL LILOCK LIF( I ) DRAPE MICROSCOPE ZEI SS( I ) TOWELS ABSORBENT 1 5" X 20"" LIF( I ) TIME OUT BEACON NON WOV EN ST LIF( I ) BLADE M INUATURE CARBON STEEL( I 0) GAUZE SPONGE 4"" X 4"" 1 6PLY XRD LIF( I ) NEEDLE BLUNT FI LL 1 80 X I Y;(2) SCALPEL SAFETY WEIGHTED # 1 5( I ) GOWN SURG; I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL( I ) MERLINO SKIN PREP APPLIC. 39ML LIF( I ) WRAPPER 24"" X 24""WET SKIN PACK CONTA INING: ( I ) WRAPPER 30"" X 30""( I ) TRAY 3/COMPARTM ENT( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE(3) TI P ABSORBENT APPLICATOR STICK SPONGE(3) TOWELS ABSORBENT 15"" X 20"" L/F (6) SPONGE WING SMALL LIF(2) GLOVE MED FREETOUCI-1 VYN I L P/F(2) COTrON APPLICATOR 6"" WOODProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PHACO PACK – (10) GAUZE SPONGE 4" X 4" 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %"(2) MEDICINE CUP 2 oz. (1) OPHTHALMIC DRAPE W/POUCH(1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS(1) EYE SHIELD UNIVERSAL (1) TABLE COVER 44" X 90"(1) MAYO STAND COVER REINF. LIF (3) ABSORBENT TOWEL 15" x 20 LIF(2) EYE PAD 2 1/8 X 2 5/8 LIF (1 0) EYE SPEAR MICRO SPONGE VELCRO/NECKEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Breast Augmentation Pack; Imagenes Cosmetic; code 900-2682:(3) GOWN SOFT SMS STD XLGE SET IN SLEEVE( 1) CAUTERY PENCIL PUSH BOTTOM( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED( 1) SKIN MARKER INK W LABEL(2) TABLE COVER REINFORCED 50 X 90( 1) RULER 6 CLEAR(6) TOWEL CLOTH HUCK (BLUE)(10) LAP SPONGE PREWASH 18 X 18 XRD( 1) CAUTERY TIP POLISHER( 1) YANKAUER SUCTION TUBE W/O VENT( 1) DRAPE BREAST/CHEST SMSProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY PACK- -(1) DRAPE LAP ABDOMINAL WITH POUCH(1) CAMARA DRAPE 9" X 96" LIF(5) TOWELS ABSORBENT 15" X 20"(1) MAYO STAND COVER REINFORCED(1) TABLE COVER REINFORCED 50" X 90"(4) DRAPE UTILITY WITH TAPE(3) DRAPE SHEET 41" X 58" SMS(1) TUBING INSUFFLAT SET W/0 RING ADAPTOR(5) LAP SPONGE PREWASH 18" X 18" XRD(1) GOWN LGE SMS IMPERVIOUS REINFORCED(2) GOWN X-LARGE SMS IMPERV. REINFORCED(2) MEDICINE CUP 2oz.(1) NEEDLE HYPODERMIC 18G X 1% ST.( 1) BLADE SURG. # 15 CARBON STEEL(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK(2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR(1) DRESSING TEGADERM 4" X 4%"(1) SOLUTION SURGICAL DURAPREP 6mL(1) TRAY MAYO SMALL(1) TUBE SUCTION CONNECT. %"X 12′(10) GAUZE SPONGE 4" X 4" 16PLY XRD(1) NEEDLE ECLIPSE 22 X 1%(1) TIME OUT BEACON NON WOVEN STEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LAPAROSCOPIA COLORECTAL PACKCONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml(4) DRAPE UTILITY WITH TAPE(1) TOWELS ABSORBENT 15"" X 20"" (2) LEGGINS W/7"" CUFF 30"" X 42""(1) BLADE SURGICAL #15 STAINLESS STEEL(1) BLADE SURGICAL #11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINFORCED XLG (1) GOWN LGE STANDARD SMS VELCRO NECK(1) IRRIGATION SUCTION TROMPET DUAL SPIKE (10) GAUZE SPONGE 4"" X 4"" 16PLY XRD(2) UTILITY BOWL 16oz(2) STERI STRIP CLOSURE W’ X 4""(1) ACTIFOG W/FOAM PAD SOLUTION(1) TABLE COVER REINFORCED 50"" X 90"" (1) MAYO STAND COVER REINFORCED (1) NEEDLE ULTRA VERES 120MM(1) STAPLE ARTICULATING ECHEL 60MM (1) RELOAD WHITE 60MM ECHELON(1) RELOAD BLUE 60MM ECHELON (2) CANNULA 5MM XCEL SLEEVES(1) TROCAR 5MM BLADELE WITH STAB SLEEVE (1) TROCAR 12MM BLADELE WITH STAB SLEEVE(1) DRAPE LAP. ABDO W/POUCH 102"" X 122"" X 78"" STD SMSProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Customed Femoral Pack ; convenience pack include multiple components: Syringe 3cc; 5cc; 10cc; 20cc; swabstick chlorascrub; needles; gauze/sponges; table cover; absrobent towels; halsted Mosquito CVD; gown; bowls; wrapper; scalpel safety; Mosquito forcep; cloth huck; clamp towel; fluorocover; medicine cup; femoral angiodrape; mayo tray; counter & labels.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT:(4) TOWEL ABSORBENT 15" X 20"(2) GOWN XLARGE SMS IMPERVIOUS REINFORCED (1) COVER MAYO STAND REINFORCED(2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL(1) DRAPE T LAPAROTOMY 102" X 78" X 121" STD SMS (1) TABLE COVER REINFORCED 50" X 90"Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF(1) TUBE SUCTION CONNECT Y.." X 12′ LIF(1) ELASTIC BANDAGE 6" X 5yrd. UF(1) IMPERVIOUS STOCKINETTE 14" X 48"(1) HUCK CLOTH TOWEL WHITE(1) MAYO STAND COVER REINFORCED LIF(1) U DRAPE 60" X70" WITH TAPE SPLIT(4) STRIPS TAPE 24" X 4" L/F(1) STOCKINETTE 6" X 48" LIF(1) MAYO TRAY SMALL(5) HUCK CLOTH TOWELS BLUE(2) UTILITY BOWL 32oz(2) GOWN SURGICAL REINFORCED X-LARGE LEVEL IV(1) SOLUTION SURGICAL DURAPREP 26ml UF(1) SHEET EXTREMITY ABS. 125" x 85" SMS(5) LAP SPONGE PREWASH XRD(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF(1) PENCIL CAUTERY ROCKER SWITCH(1) SKIN MARKER INK WITH 8 LABEL(2) LITES GLOVES UF(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR(1) CAUTERY TIP POLISHER UF(4) DRAPE UTILITY WITH TAPE UF(1) BAG BIOHAZARD 30" X 37"(1) BAG SUTURE FLORAL(1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF(1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAPEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LAPAROTOMY PACK 1 (2&3) CUSTOMEDCONTENT: (2) TOWEL ABSORBENT 15"" X 20""(1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE(1) SUTURE BAG FLORAL(1) DRAPE T LAPAROT 102"" X 78"" X 121"" STD SMS (1) TABLE COVER REINFORCED 50"" X 90""Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LAPAROTOMY PACK BASICCODE 900-2829CONTENTS: (2) TOWELS ABSORBENT 15"" X 20""(1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE(1) BAG SUTURE FLORAL(1) DRAPE T LAPAROT 102"" X 78"" X 121"" STD SMS(1) COVER TABLE REINFORCED 50"" X 90""(1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill(1) TIME OUT BEACON NON WOVEN(1) COUNTER NDUBLADE 20C FOAM/MAG(1) SKIN MARKER INK W/8 LABEUTIME OUT/RULER(1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP AAMI LEVEL IllProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Chole Cystectomy All Endo System ; code 900-3025; contains:(1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF(2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF(4) UTILITY DRAPE WIT APE UF (1) TROCAR DILATING XCELL 5MM X 100(3) GOWN XL SURGICAL MICROCOOL L/F (1) TROCAR ENDOPATH XCEL DILATING TIP(1) WRAPPER 24" X 24" UF (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF(1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF (5) APPLICATOR COTTON 6 WOOD UF(1) ULTRA VERES NEEDLE 120MM LIF (1) APPLIER MUL Tl CLIP W/SHAF GUN(1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF (2) DRAPE :Y. ECONOMY 53" X 77" UF(2) UTLITY BOWL 16oz. UF (1) SCALPEL WEIGHTED SAFETY #11 UF(1) RING BASIN (1) TIME OUT BEACON NON WOVEN UF(1) TUBE SUCTION CONNECT (1) MERLING SKIN PREP APPLIC 39ML UF(1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF (2) TOWEL CLOTH HUCK (BLUE) UF(1 0) GAUZE SPONGE 4 X 4 16PL Y UF (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM(5) LAP SPONGE PRE-WASH 18" X 18" XRD UF (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM(1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF (2) LIGHT SHIELD UF(1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6(1) DRAPE LASER CAMERA W/ELASTIC 6X 96 (1) PK. STERI STRIP CLOSURE (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF (1) MAYO TRAY SMALL(1) SYRINGE 30ML SLIP TIP 1 ML UFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – C-SECTION PACK – (1) TABLE COVER REINFORCED 50" X 90" L/F(3) TOWELS ABSORBENT 15" X 20" L/F(1) BABY BLANKET(1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF(1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV(2) PAD OBSTETRICAL XL LIF(1) LITE GLOVE LIF(1) DRAPE SHEET 41" X 69" MEDIUM LIF(2) SURGICAL BLADE #10 CARBON STEEL(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF(1) BAG GLASSINE(2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR(1) CONTAINER 64oz WITH LID(1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF(1) MAYO STAND COVER REINFORCED UF(1) BAG SUTURE FLORAL(15) LAP SPONGES PRE-WASH XRD LIF(1) EAR ULCER SYRINGE 2oz UF(1) CORD UMBILICAL CLAMP L/F(1) WASH BASIN ?QT.(1) CAUTERY TIP POLISHER LIF(1) YANKAUER SUCTION TUBE W/0 VENT LIF(1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78"(1) FEEDING TUBE 8FR. 15" LONG(4) DRAPE UTILITY WITH TAPE UF(1) TUBE SUCTION CONNECT. Y." X 12′ UF(2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IVEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – VEIN PACK – (1) GOWN STANDARD LARGE SMS VELCRO/NECK(3) LAP. SPONGES PREWASH XRD LIF(1) EXTREMITY SHEET ABS LIF(1) WRAPPER 36" X 36"(1) IMP. STOCKINETTE 14" X 48" LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – D & C LAPAROSCOPY PACK – (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT(1) MAYO STAND COVER REINFORCED UF(4) DRAPE UTILITY UF(1) TRAY MAYO SMALL LIF(1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL(1) SUTURE BAG FLORAL LIF(1) TUBE SUCTION CONNECT X" X 12′ LIF(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF(2) LEGGINGS WITH 7" CUFF 30" X 42" LIF(1) UTILITY BOWL 32oz. UF(1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX(2) DRESSING NON ADH TELFA 4 X 3 ST. UF(1) JELLY LUBRICATING FIVE GRAM(1) TABLE COVER REINFORCED 50" X 90" LIF(1) *Pk. STERI STRIP LAP SET LATEX(1) COVER CAMERA W/ELAST UF(2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF(4) TOWELS ABSORBENT 15" X 20" UF(1) DRAPE LAP. PERINEAL WITH POUCH 102" X 97" SOFT SMS UF(2) LIGHT SHIELD(1) DRESSING TEGADERM 4" X 4 %" LIF(10) GAUZE SPONGE 4" X 4" 16PLY XRD UF(1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP(1) SCALPEL WEIGHTED SAFETY #11(1) BAG ZIP LOCK(1) Pk. STRIP STERI CLOSURE W’ X 4" LIF(1) TIME OUT BEACON NON WOVEN ST. UF(1) BANDAGE GAUZE STRETCH 4"(1) NEEDLE ULTRA VERES 120MM UF(2) COUNTER NDUBLADE; 10C MAG/CLEAR UF(1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12′(1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING(1) TUR Y SET; 2 LEAD; ST. (1) BAG SUTURE FLORAL(1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP(1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0" x 63" (2) SHEET DRAPE 41 " X 58" SMS(1) COVER TABLE REINF 50" X 90" (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX(3) TOWELS ABSORBENT 15" X 20" (1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV(1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TIME OUT BEACON NON WOVEN ST.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – UNIVERSAL PACK – (1) TRAY ORGANIZER FULL DEEP(1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF(1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF(1) NEEDLE HYPODERMIC 20G X 1 ~ UF(2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill(1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF(1) SHEET% 57" X 63" REINFORCED SMS LIF(2) TOWELS ABSORBENT 15" X 20" LIF(4) DRAPE UTILITY LIF(1 0) GAUZE SPONGES 4" X 4" 12PL Y LIF(4) CLOTH HUCK TOWELS BLUE LIF(1) TABLE COVER REINFORCED 50" X 90" UF(1) SCALPEL WITH HANDLE #11(1) DENTURE CUP WITH LID(1) TRAY 2 COMPARTMENT(2) ABSORBENT TIP APPLICATOR(1) IMPERVIOUS STOCKINETIE 14" X 48" LIF(1) TAPE TRANSPORE 1" X 36"(1) DIISP NEEDLE 30 X ~(1) PROBE DRAPE 6" X 96 WITH GEL(1) ARTERIAL NEEDLE 18 X 2 %(1) CATHETER INTRODUCER 7FR(1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – RETINA PACK – (1) TABLE COVER REINFORCED 44" X 78" LIF(50) COTTON TIP APPLICATOR 6" WOOD LIF(2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE(2) MEDECINE CUP 2oz LIF(5) TOWELS ABSORBENT 15" X 20" LIF( 1) UNIVERSAL EYE SHIELD(1) EYE DRAPE(1) BIPOLAR CABLE DISPOSABLE( 1) OPHTALMIC BIPOLAR PENCIL(10) GAUZE SPONGE 4" X 4" 16PLY(2) EYE PAD 2 1/8 X 2 5/8 ST.( 1) MAYO STAND COVER REINFORCED LIF( 1) KNIFE 15 5.0 CONTROLLED DEPTH.(1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF(1) SURGICAL BLADE #15 STAINLESS STEEL(3) SYRINGE 1CC TUBER. 25G X 5/8 SLIP TIP L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF(2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF(1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF(10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE(1) GOWN LGE STD SMS (1) WIPE INSTRUMENT 1MM(1) EYE DRAPE UF (1) LABEL XYLOCAINE FOR MEDICATION YELLOW(1) IODINE POVIDONE 1oz. (1) EYE SHIELD UNIVERSAL L/F(10) APPLICATOR COTION 6" WOOD (1) BALANCED SALT SOLUTION 18ML LIF(10) GAUZE SPONGE 4" X 4" 12P Y UF (1) LABEL BSS(1) TRAY 3/COMPARTMENT LIF (1) LABEL EPINEPHRINE VIOLET/WHITE(1) LABEL IODINE WHITE/BLACKProduct Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Breast Pack- FJG; code 900-3118; contains:(2) GOWN LARGE STANDARD SMS AAMIIII(2) TOWEL ABSORBENT 15" X 20"(1) PENCIL CAUTERY PUSH BOTTOM(1) SYRINGE BULB 60CC(1) TUBE SUCTION CONNECT~" X 12′(1) COUNTER NEEDLE & BLADE 20C FOAM/MAG(1) BOWL UTIL TIY QUART 32oz(1) COVER MAYO STAND REINFORCED(2) SKIN MARKER WITH RULER(2) RULER(1) COVER TABLE REINFORCED 50" X 90"(2) CUP DENTURE 8oz TEAL WITH LID(6) TOWEL CLOTH HUCK BLUE(2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK(1) YANKAUER SUCTION TUBE WITHOUT VENT(1) DRAPE BREAST/CHEST SMS(10) SPONGE LAP PREWASH 18" X 18" XRD(1) SHEET% DRAPE REINFORCED 60" X 77"(4) DRAPE UTILITY WITH TAPE(1) BLADE SURG. #15 CARBON STEEL(2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 POWDER FREE(2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 POWDER FREE(1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 POWDER FREE(10) GAUZE SPONGE 4" X 4" 16PLY(1) PK. STRIP STERI CLOSURE W’ X 4"(1) NEEDLE SPINAL ANESTH 22G X 3Y2(1) NEEDLE HYPODERMIC 22G X 1Y2(1) IV PRIMARY ADD ADMINISTRAT SET(1) STOPCOCK 3WAY WSWIVEL MALE(1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCKProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – ORTHO PACK EXTREMITYCUSTOMEDCONTENTS: (1) TABLE COVER REINFORCED 50"" X 90"" (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL(1) STOCKINETTE IMPERVIOUS 14"" X 48""(1) U-DRAPE 60"" X 70"" WfTAPE SPLIT (1) SHEET EXTREMITY ABS. 125"" X 85""(1) GOWN SOFT SMS STD. XLGE SET IN SLEEVE(1) WRAPPER 24"" X 24""(1) TOWELS ABSORBENT 15"" X 20""Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Liposuction Pack BOD; code 900-3028; contains:(2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill(2) LITE GLOVES LIF(2) TOWEL ABSORBENT 15" X 20" L/F(1) NEEDLE HYPODERMIC 27G X 1 %" LIF(1) BOWL UTILITY QUART 32oz TURQ(1) COVER MAYO STAND REINFORCED L/F(1) PVP SCRUB SOLUTION 4oz(2) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF(2) COVER TABLE REINFORCED 44" X 78" LIF(1) CUP DENTURE 8oz TEAL WITH LID(12) TOWEL CLOTH HUCK C BLUE LIF(1) SAFETY SCALPEL #15 DISPOSABLE LIF(2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF(1) TUBING INFILTRATION PERISTALTIC PUMPS(4) CLAMP TOWEL LIF(3) SHEET DRAPE 70" X 100" LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROTOMY PACK – (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD(I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill(2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR( I) DRAPE LAPAROT ABDOM WITH POUCH(2) TOWELS ABSORBENT 15" x 20" ( I) TIME OUT BEACON NON WOVEN(4) DRAPE UTILITY (I) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER(I) MAYO STAND COVER REINFORCED ( I) SUTURE BAG FLORAL(I) TABLE COVER REINFORCED 50" X 90" ( I) GOWN IMP EXTRA REINF LGE TOWEUWRAP(2) DRAPE SHEET 42" X 55" SMS (I) CAUTERY TIP POLISHER(I) CAUTERY PENCIL ROCKER SWITCH ( I) BAG GLASSINE(I) SURGICAL BLADE# 10 STAINLESS STEELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PREMIUM CESAREAN PACK- CUSTOMED-(1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT(3) TOWELS ABSORBENT 15" X 20" LIF(1) BOWL PLASTIC 80oz WITH LID(10) LAP SPONGE PREWASH XRD LIF(2) PAD OBSTETRICAL X-LARGE ST.(1) MAYO STAND COVER REINFORCED LIF(1) DRAPE SHEET 41 " X 58" SMS LIF(1) TUBE SUCTION CONNECT. X" X 12′ LIF(1) EAR ULCER SYRINGE 2oz LIF(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF(1) CORD UMBILICAL CLAMP LIF(1) DRESSING ISLAND 4" X 10"(1) BLADE SURGICAL#10 CARBON STEEL(1) BLADE SURGICAL#20 CARBON STEEL(1) TABLE COVER REINFORCED 50" X 90" LIF(1) C-SECTION DRAPE WITH POUCH(1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III(1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAPEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Shoulder Pack; Code 900-2616; contains:(2) TUBE SUCTION CONNECT Y."X12′ UF (1) SYRINGE 20CC W/0 NDL UL UF(2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF(5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF(1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) DRAPE BEACH CHAIR SHOULDER UF(1) CO BAN WRAP 4"X5 YRD LATEX (1) GOWN IMP. XTRA REINF. X-LGE UF(1) TUR Y SET 81" 2.1M REG. CLAM (1) GOWN IMP. POL YREINF XLGE T/WRAP UF(1) TABLE COVER REINF. 50" X 90" UFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY PACK – -(1) MAYO STAND COVER REINFORCED LIF(2) DRAPE % ECONOMY 53" X 77" LIF(1) TUBE SUCTION CONNECT. v.i" X 12′ LIF(1) SCALPEL WITH HANDLE #11(1) DRAPE LAP ABDOMINAL WITH POUCH 1 02" X 122" X 78" LIF(1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF(8) TOWEL ABSORBENT 15" X 20" L/F(1) TABLE COVER REINFORCED 50" X 90" L/F(1) *LAPAROSCOPIC WOUND CLOSURE LATEX(1) DRAPE LASER CAMERA WITH/EL 6" X 96" LIF(4) DRAPE UTILITY WITH TAPE L/F(3) GOWN IMPERVIOUS REINFORCED X-LARGE SMS L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY~OBPACK – (4) ABSORBENT TOWELS 15" x 20" LIF(2) LEGGINS WITH 7" CUFF(1) LAPAROSCOPY T SHEET SMS(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF(1) NEEDLE HYPODERMIC 18G X 1%(1) *ROBIN REDRUBBER CATHETER 14FR LATEX(1) DRAPE LASER CAMERA W/EL LIF(1) PAD OBSTETRICAL X-LARGE 6" X 96" LIF(3) TOWEL CLAMP(4) DRAPE UTILITY WITH TAPE LIF(1) GOWN SURGICAL POLY REINFORCED BREATHABLE IMP LARGE LEVEL IV(2) GOWN SURG POLY REINFORCED BREATHABLE IMP XL SMS LEVEL IV(20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF(1) TABLE COVER 44" X 90"(1) MAYO STAND COVER REINFORCED LIF(1) SURGICAL BLADE #15 CARBON STEEL(1) LITE GLOVE LIF(1) DRESSING NON-ADHESIVE TELFA 4" X 3"(1) TUBE SUCTION CONNECT Y4" X 12′ LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Tummy Tuck and Liposuction Pack; code 900-2661; contains:( 1) DRAPE % ECONOMY 53 X 77(3) GOWN SOFT SMS STANDARD X-LARGE SET IN SLEEVE(3) TOWELS ABSORBENT 15 X 20(1) MAYO STAND COVER REINFORCED(1) TABLE COVER REINFORCED 50 X 90( 1) SUTURE BAG FLORAL(6) TOWEL CLOTH HUCK BLUE(1) BLADE SURGICAL CARBON STEEL 10(1) BLADE SURGICAL CARBON STEEL 11(4) PAD ABDOMINAL 8 X 7.5( 1) CAUTERY TIP POLISHER(2) LITE GLOVES( 1) YANKAUER SUCTION TUBE WITHOUT VENT(20) LAP SPONGE PREWASH 18 X 18 XRD(1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER(1) UNDERPAD 23 X 36( 1) TUBE SUCTION CONNECT 1/4 X 12(1) DRAPE BREAST/CHEST SMSProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Endovascular Pack; code 900-2715; contains:( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF(2) TOWELS ABSORBENT 15 X 20 LIF( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf(2) BAG BAND FLUOROSCOPE 36 X 30 LIF( I) NEEDLE HYPODERMIC 21G X I Y; LIF(2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI III LIF(2) SOLUTION SURGICAL DURAPREP 6ML LIF( I) BAG BAND RUB BAND & TAPE 42 X 38 LIF(4) TOWELS CLOTH HUCK BLUE LIF(I) Pr. GLOVE SYNTEGRA CR 6.5 POWDER FREE Llf(2) Pr. GLOVE SYNTEGRA CR 8 POWDER FREE LIF( I) NEEDLE HYPODERMIC 25G X 5/8 LIF( I) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK LIF(I) COYER TABLE 44 X 90 LIF( I) SCALPEL WITH HANDLE (25) GAUZE SPONGES 4 X 4 12PLY LIF(2) CLAMP TOWEL(2) SYRINGE I OCC WITHOUT NEEDLE LUER LOCK LIF( I) NEEDLE HYPODERMIC 18G X I Y; LIF( I) SHARP STOP NEEDLE HOLDER LIF( I) TRAY ORGANIZER FULL DEEP( I) NEEDLE 18G X 23(I) BOWL UTILITY BLUE 16oz LIF( I) WRAPPER 24X 24 LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Universal Pack- – (1) TABLE COVER REINFORCED 50" X 90" LIF(3) TOWEL ABSORBENT 15" X 20" LIF(1) MAYO STAND COVER REINFORCED LIF(1) TUBE SUCTION CONNECT. X" X 12′ LIF(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF(1) BAG SUTURE FLORAL(1) DRAPE TOP WITH ADHESIVE 100" X 53" LIF(1) DRAPE BOTTOM ASS REINFORCED 71" X 71" WITH TAPE LIF(1) CAUTERY TIP POLISHER LIF(3) SURGICAL BLADE #1 0 CARBON STEEL(15) LAP SPONGE PREWASH XRD LIF(1) BAG GLASSINE(2) DRAPE SIDE WITH ADHESIVE 36" X 77"(2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F(1) LITES GLOVE LIF(3) SURGICAL BLADE #15 CARBON STEEL(1) SPECIMEN CONTAINER 4oz WITH LID & LABEL(1) WRAPPER 24" X 24"(3) GOWN SURG SMS POLY-REINF. BREATHABLE IMP XLGE AAMI IVEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ARTHROSCOPY PACK – -(1) MAYO STAND COVER REINFORCED LIF(3) TOWELS ABSORBENT 15" X 20" LIF(1) STOCKINETTE IMPERVIOUS 14" X 48" LIF(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF(1) BLADE SURGICAL # 11 STAINLESS STEEL(1) NEEDLE HYPODERMIC 21G X 1 ~ LIF(1) TUR Y SET 81" 2.1M REGULAR CLAM(1) NEEDLE HYPODERMIC 18G X 1 ~(1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF(1 0) GAUZE SPONGE 4" X 4" 16PL Y(1) SHEET DRAPE 70" X 100" LIF(1) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX(2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS(1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF(1 ) TUBE SUCTION CONNECT. X" X 12′ LIF(1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21"(1 ) DURAPREP SURGICAL SOLUTION 26ML LIF(1 ) NEEDLE SPINAL ANEST. 18G X 3 %" LIF(2) ELASTIC BANDAGE 6" X 5YRD. LIF(1) TABLE COVER REINFORCED 50" X 90" LIF(1) PAD ABDOMINAL 8" X 7.5"(1) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEXEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Open Heart Pack; code 900-2618; contains:(9) DRAPE 60" X 76" REINFORCED LIF( 1) MAYO STAND COVER REINFORCED LIF(6) TOWELS ABSORBENT 15" X 20" L/F( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF( 1) MAYO TRAY LARGE(8) DRAPE UTILITY WfTAPE LIF(1 ) TABLE COVER REINFORCED 44" X 78" LIF(2) GOWN SURG. SMS POLY-REINF BREATHABLE AAMI IV X-LARGE T/WRAP( 1) DRAPE SPLIT CARDIO W/CLEAR ANEST. SC STD SMS( 1) SHEET SPLIT BILATERAL 84" X 80" LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – KNEE ARTHROSCOPY PACK 4CUSTOMEDCONTENTS: (1) COVER TABLE REINFORCED 50"" X 90""(1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill (1) PRE PAD CUFF(1) COVER MAYO STAND REINFORCED(1) BAG SUTURE FLORAL(1) SHEET SPLIT WITH/ADHESIVE 108"" X 77"" STD SMS(1) STOCKINETTE IMPERVIOUS 12"" X 48"" (4) STRIPS TAPE 24"" X 4""(1) DRAPE ARTHROSCOPY W/POUCH (1) TOWEL ABSORBENT 15"" X 20"" Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF(1) CAUTERY TIP POLISHER LIF(1) BAG SUTURE FLORAL L/F(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF(20) GAUZE SPONGES 4" X 4" 4PL Y(1) COVER TABLE REINFORCED 50" X 90" LIF(2) GOWN IMPERVIOUS REINFORCED LARGE SMS(1) PENCIL CAUTERY HANDSWITCHING L/F(1) TUBE SUCTION CONNECT. ~; X 12′ LIF(1 0) LAP SPONGE PRE-WASH XRD LIF(2) LITE GLOVE LIF(4) HUCK CLOTH TOWEL BLUE(2) DRAPE SHEET MEDIUM 41" X 69" LIF(2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF(1) DRAPE LAP ABDOMINAL WITH POUCH STD SMS(5) Pk. STERI STRIP CLOSURE %"X 4" L/F(1) MAGNETIC INST. DRAPE(3) SKIN MARKER WITH RULER LIF(1) EXTENDED ELECTRODE BLADE(2) ABSORBENT TOWEL 15" X 20" LIF(4) UTILITY BOWL 32 oz(2) SURGEON GLOVES #8 BIOGELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Customed Laparoscopy convenience pack include multiple components: gowns; table covers; needle and blade counter; bag suture; suture; sponges/gauzes; containers; syringes 20cc & 30cc w/o needle; needle; drape; tubing; towel; dressing island; and blade surgical SS.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ARTHROSCOPY PACK – (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF(1) TUBE SUCTION CONNECT ~" X 12′ LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF(1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F(1) BLADE SURGICAL# 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1Y2 LIF(1) NEEDLE SPINAL ANESTH 18G X 3 Y2 LIF (1) PAD ABDOMINAL 8" X 7.5" LIF(2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds LIF (1) TIME OUT BEACON NON WOVEN LIF(1) NEEDLE HYPODERMIC 18G X 1 Y2 L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF(1) COVER TABLE 44" X 90" LIF (1) COUNTER NDLIBLADE 20C FOAM/MAG L/F(3) TOWELS ABSORBENT 15" X 20" LIF (1) BAG SUTURE FLORAL(1) SHEET DRAPE 70" X 1 00" SMS LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y(1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE AAMI(1) TUR Y SET 81"2.1M REGULAR CLAM LIF LEVEL Ill TOWEL/WRAP LIF(1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" UF(1) GOWN XL SMS IMPERVIOUS REINFORCED AAMILEVEL Ill LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – BASIC COSMETIC SURG. PACKCUSTOMED (USA); CODE 900-2915.CONTENTS: (2) TOWELS ABSORBENT 15"" X 20"" LIF (1) DRAPE BREAST/CHEST SMS L/F(1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) TUBE SUCTION CONNECT Yt"" X 12′ LIF(1) YANKAUER SUCTION TUBE W/0 VENT L/F (1) STERI STRIP CLOSURE%"" X 4"" L/F(1) BLADE SURG. #15 CARBON STEEL(1) NEEDLE HYPODERMIC 25 X 1 % LIF(5) LAP SPONGE PREWASH 18"" X 18"" XRD LIF(1) PENCIL CAUTERY ROCKER SWITCH W/ HOLSTER LIF (1) SYRINGE 60cc THUMB CONT. RING CATH. TIP LIF(1) COVER TABLE REINFORCED 50"" X 90"" LIF(1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL(2) GOWN SOFT SMS STD. XL SET IN SLEEVE LIF(4) DRAPE UTILITY WITH TAPE L/F (4) TOWEL CLOTH HUCK LIF(1) WRAPPER 24"" X 24""Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – REYITO UROLOGY PACK – (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF ( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF( I) BAG SUTURE (I) TABLE COVER( I} TUBE SUCTION CONNECT. W’ X 12′ UF (10) GAUZE SPONGES 4" X 4" 16PLY( I) EMESIS BASIN (I) DRAPE LASER CAMERA W/E( I} UTILITY BOWL32oz (I) BOWL PLASTIC 80oz WITH LID( I) SYRINGE IOcc W/0 NDL. LUER LOCK UF (I} SYRINGE IOcc PREFILLED WITH GEL(5) CONTAINER SPECIMEN 4oz W/LID & LABEL (I) GOWN SURG. REINFORCEDT/WRAP X-LARGE( I} TUR Y SET; 2LEAD UF ( I} DRAPE LITHO 11 0" X 63" WI POUCH WILEGGING( I} ROUND WASH BASIN 6QT.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – E..N.T. PACK – (5) SPONGE TONSIL 7/8 XRD(1) TABLE COVER REINFORCED 50" X 90" LIF(1) MAYO STAND COVER REINFORCED L/F(1) TUBE SUCTION CONNECT %" X 12′ L/F(1) CAUTERY TIP POLISHER LIF(1) SUTURE BAG FLORAL(2) CONTAINER SPECIMEN 4oz WITH LID & LABEL(1) CAUTERY PENCIL HAND SWITCHING(2) ABSORBENT TOWELS 15" X 20" L/F(1) DRAPE SHEET 41 " X 58" SMS L/F(1) EAR/ULCER SYRINGE 2oz LIF(2) MEDICINE CUP 2oz(1 0) GAUZE SPONGE 4" X 4" 16PL Y(1) *Pr. SURGICAL GLOVES #7% POWDER(1) *Pr. SURGICAL GLOVES #7 POWDER(9) LABEL FOR SKIN MARKEREO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – BASIC PACK – (1) TABLE COVER REINF. LIF(1) MAYO STAND COVER REINF. LIF(2) TOWELS ABSORBENT LIF(10) GAUZE SPONGES XRD 4" X 4" 12PLY(2) DRAPE SHEET 41" X 58" SMS(4) DRAPE UTILITY WIT APE L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH(2) ABSORBENT TOWELS 15" x 20" UF (2) LEGGINS W/7" CUFF 30" X 42"(1) TABLE COVER REINFORCED 50" X 90" UF (1) ABDOMINAL DRAPE WITH TAPE UF(1) UTILITY BOWL 16oz. (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF(1) PAD OBSTETRICAL XL LIF (2) SPECIMEN CONTAINER 4oz. W/LID & LABEL(1 ) SYRINGE 1 Occ PREFILLED W/GEL (1 ) DRAPE SHEET 41 " X 69" MEDIUM UF(1 ) CATHETER 14FR. ROB. NELAT (1) NON-ADHESIVE TELFA DRESSING(2) GOWN IMP. REINFORCED LGE SMSEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc; gauze; denture cup; specimen container; band bag; glove; gown; needle hypodermic; absorbent towels; table cover; scalpel;cloth huck towel;iodine povidone;applicator sponge;towel clamp; femoral angiography drape;needle 18G;& GuidewireEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY CHOLE PACK – -( 1) STRIP STERI CLOSURE W’ X 4" LIF( 1) TABLE COVER REINFORCED 50" X 90" LIF( 1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF(2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F(5) TOWELS ABSORBENT 15" X 20" LIF(5) LAP SPONGE PREWASH 18" X 18" XRD LIF(4) DRAPE UTILITY WIT APE LIF( 1) COVER CAMERA W/ELAST LIF(2) GAUZE SPONGE 4" X 4" 12PL Y LIF( 1) NEEDLE ULTRA VERES 120mm LIF(2) DRAPE SHEET 41 " X 58" SMS LIF( 1) SCALPEL WEIGHTED SAFETY #11( 1) TUBING INSUFFLATING OPEN TIP W/0 VENT LIF( 1) DRESSING TEGADERM 4" X 4 %" LIF( 1) TUBE SUCTION CONNECT X" X 12′ LIF( 1) MAYO STAND COVER REINFORCED LIF( 1) SUTURE BAG FLORAL LIF( 1) Pk. STERI STRIP LAP SET LATEX( 1) CORD LAPAROSCOPY MONOPOLAR LIF( 1) MAYO TRAY SMALL LIF( 1) TIME OUT BEACON NON WOVEN ST. LIF(1) SKIN MARKER INK W/8 LABEL TIME OUT/RULER LIF( 1) BAG ZIP LOCK PLASTIC 6" X 10"EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Liposuction Pack; code 900-2681; contains:(3) GOWN SOFT SMS STD XLGE SET IN SLEEVE(1) TUBE SUCTION CONNECT(1) MAYO STAND COVER REINFORCED(1) SKIN MARKER INK W LABEL(2) TABLE COVER REINFORCED 50 X 90(1) RULER 6 CLEAR(12) TOWELS CLOTH HUCK (BLUE)(1 0) LAP SPONGE PREWASH 18 X 18 XRD(1) CAUTERY TIP POLISHER(20) GAUZE SPONGE 4X 4 12PL Y(4) TOWEL CLAMP(1) Y CONNECTOR (1) CAUTERY PENCIL PUSH BOTTOM(3) DRAPE SHEET 98 X 63 STD SMSProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Tummy Tuck Pack; code 900-2684; contains:(3) GOWN SOFT SMS STD XLGE SET IN SLEEVE( 1) CAUTERY PENCIL PUSH BOTTOM( 1) TUBE SUCTION CONNECT( 1) MAYO STAND COVER REINFORCED( 1) SKIN MARKER INK W LABEL(2) TABLE COVER REINFORCED 50 X 90( 1) RULER 6(6) TOWEL CLOTH HUCK (BLUE)(10) LAP SPONGE PREWASH 18 X 18 XRD( 1) CAUTERY TIP POLISHER( 1) DRAPE BREAST/CHEST SMSProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LUMBAR PACKADVANCED AMBULATORY SURGICAL CENTERCONTENTS: (1) COVER TABLE REINFORCED 50"" X 90"" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4"" X 4"" 16PLY XRD UF (1) STRIP STERI DRAPE LARGE 17"" X 23"" UF(1) SCALPEL WITH HANDLE #11 (1) COVER FLUORO 30"" X 30"" WITH RUBBER BAND UF (1) DRAPE CHEST 100"" X 142"" X 72"" (1) RULER FLEXIBLE PLASTIC(1) SOLUTION SURGICAL DURAPREP 26ML UF (1) SHEET :X 60"" X 77"" DRAPE REINFORCED UF(1) STRIP STERI CLOSURE%" X 4"" UF (2) GOWN SOFT SMS STD. XL SET IN SLEEVE UF (4) NEEDLE HYPODERMIC 18G X 1 % U (1) SKIN MARKER W/RULER UF(1) NEEDLE HYPODERMIC 25 X 1 % UF (1) DRESSING TELFA 8"" X 3"" NON ADH UF(1) DRESSING TEGADERM 4 X 4%"" UF (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VIALL /F (1) BAG ZIP LOCK UF (9) LABELS FOR SKIN MARKERS UFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15"" X 20""(2) LEGGINGS W/7" CUFF 30"" X 42"" CSR(1) DRAPE UNDERBUTTOCK WITH POUCH 44"" x 35""(1) DRAPE ABDOMINAL WITH TAPE 40"" X 54""(1) DRAPE UTILITY WITH TAPE(1) TABLE COVER REINFORCED 50"" X 90""(1) TIME OUT BEACON NON WOVEN ST.Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PREMIUM LAPAROTOMY PACK – CUSTOMED-(1) DRAPE T LAPAROT 102" X 78" X 121"(1) GOWN XL SMS IMPERVIOUS REINFORCED(1) COVER TABLE REINFORCED 50" X 90" LIF(1) COVER MAYO STAND REINFORCED LIF(4) DRAPE UTILITY WITH TAPE LIF(4) TOWELS ABSORBENT 15" X 20" LIF(5) SPONGE LAP PRE-WASH 18" X 18" XRD LIF(1) YANKAUER SUCTION TUBE W/0 VENT LIF(1) TUBE SUCTION CONNECT~~~ X 12′ LIF(1) BLADE SURGICAL #10 CARBON STEEL(1) BLADE SURGICAL #15 CARBON STEEL(1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF(2) DRAPE SHEET 42" X 55" LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.(1) GOWN SURG REINFORCED LARGE TOWEL/WRAP Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Gown Impervious ; Code 900-3190; contains:GOWN IMPERVIOUS EXTRA LONG X-LARGEWITH TOWEL & WRAPProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Liposuction Pack FJG; code 900-3115; contains:(2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF(2) TOWEL ABSORBENT 15" X 20" LIF(1) NEEDLE HYPODERMIC 25 X 1 LIF(1) BOWL UTILITY QUART 32oz LIF(1) COVER MAYO STAND REINFORCED L/F(20) GAUZE SPONGE 4" X 4" 16PLY LIF(1) COVER TABLE REINFORCED 44" X 78" LIF(2) CUP DENTURE 8oz TEAL WITH LID LIF(6) TOWEL CLOTH HUCK BLUE LIF(1) SAFETY SCALPEL #15 DISPOSABLE LIF(1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF(4) DRAPE UTILITY WITH TAPE L/F(1) SHEET% DRAPE REINFORCED 60" X 77" LIF(1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F L/F(2) PR. GLOVE SURG CUSTOMGUARD CHLOROPRENE #6.5 P/F L/F(1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS L/F(1) DRAPE BOTTOM ABS REINF. 71" X 62" STD SMS WITH TAPE L/F(2) DRAPE SIDE 42" X 76" WITH TAPE LIF(1) PVP IODOPHOR BOTTLE 4oz PAINT(1) SUCTION TUBING 8′ X 3/8" ID NON CONDUCTIVE LIF(1) STRIP STERI CLOSURE Y2" X 4"Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15"" X 20""(2) GOWN XL SMS IMPERV. REINFORCED(1) MAYO STAND COVER REINFORCED (1) SUTURE BAG(1) DRAPE UTILITY WITH TAPE(1) STOCKINETTE IMPERV. 14"" X 48""(1) U-DRAPE 54 X 72 WITH TAPE SPLIT HIP DRAPE 89"" X 128"" WITH POUCH TABLE COVER REINFORCED 50"" X 90""Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents" Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Minor Pack 900-2511; pack contains:(1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII(10) GAUZE SPONGE 4" X 4" 16PLY XRD(5) LAP SPONGE PREWASH 18" X 18" XRD(1) DRAPE LAPAROTOMY W/POUCH 100" x 72" x 124"(4) DRAPE UTILITY WITH TAPE(2) DRAPE SHEET 41" X 69" MEDIUM( 1) MAYO STAND COVER REINFORCED( 1) GOWN SURG XLGE REINFORCED TOWEL & WRAP AAMIIII( 1) BLADE SURGICAL STAINLESS STEEL# 10(2) LIGHT SHIELD( 1) CAUTERY PENCIL ROCKER SWITCH( 1) TABLE COVER REINFORCED 50" X 90"( 1) UTILITY BOWL BLUE 16oz( 1) TOWELS ABSORBENT 15" X 20"( 1) SOLUTION SURGICAL DURAPREP 6MLProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Customed LABOR & DELIVERY PACK – Includes: (1) TABLE COVER 44" x 90"(2) LEGGINS WITH/7" CUFF 30" x 42"(5) ABSORBENT TOWELS 15" x 20" LIF(1) BABY BLANKET PRINTED LIF(2) PAD OBSTETRICAL XLGE LIF(1) EAR ULCER SYRINGE 2oz. LIF(1) BABY BLANKET POLY ABS. IMP. LIF(1) Pr. SURGICAL GLOVE # 7Y2(1) UNDER BUTTOCK DRAPE WITH POUCH(1) BEANNIES BABY LIF(1) FEEDING TUBE 8 Fr. 15" LONG LIF(1) ABDOMINAL DRAPE WITH TAPE L/F(1) DRAPE SHEET 41 " X 58" SMS(1) GOWN SURG. REINFORCED X-LARGE SMS LEVEL IV(1) VAGINAL SPONGE XRD(1) UMBILICAL CORD CLAMP LIF(2) CLOTH HUCK TOWELS BLUE(1 0) GAUZE SPONGE 4" X 4"16 PLY XRD LIF(1) SYRINGE 1 Occ WITH NEEDLE 21 X 1 Y2(1) MUCUSTRAP 20cc 1 OFr.(1) BOWL PLASTIC 80oz WITH LID(1) WRAPPER 24" X 24" LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Gown Surgical Soft SMS Non Reinforced; code 900-2725; contains:(1) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE(1) TOWEL ABSORBENT 15" X 20"(1) WRAPPER 24" X 24"Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CESAREAN PACK- (1) BEANNIES BABY LIF(1) TABLE COVER REINFORCED 50" X 90" LIF(1) COVER MAYO STAND REINFORCED LIF(3) SHEET DRAPE 41 " X 58" SMS LIF(5) TOWEL ABSORBENT 15" X 20" LIF(15) SPONGE LAP PREWASH 18" X 18" XRD LIF(1) YANKAUER SUCTION TUBE W/0 VENT L/F(2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR LIF(2) PAD OBSTETRICAL X-LARGE LIF(1) SYRINGE EAR/ULCER 2oz. L/F(1) BLANKET BABY PRINTED(1) TUBE SUCTION CONNECT Y-1" X 12′ LIF(1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF(1) BLANKET RECEIVING 100% COTTON(1) BOWL W/LID PLASTIC 80oz.(1) UMBILICAL CORD CLAMP(1) TUBE FEEDING PVC 8FR 15" LONG(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF(1) BAG SUTURE FLORAL(2) GLOVE MEDIUM FREETOUCH VYNIL POWDER FREE(1) SCALPEL W/HANDLE #1 0(1) SCALPEL W/HANDLE #20(2) BOWL UTILITY 16oz. LIF(1) PVP PAINT 8" STICK SPONGE LIF(1) GOWN SURG REINFORCED X-LARGE TOWEL/ WRAP LIF(1) PENCIL CAUTERY HAND SWITCHING LIF(1) SCISSOR UMBILICAL 4.5" STRAIGHT(1) WRAPPER 24" X 24" LIF(1) PVP SCRUB 8" STICK SPONGE LIF(1) DRAPE C-SECTION W/POUCH 102" X 121" X 78" LIF(1) TIME OUT BEACON NON WOVEN LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15"" X 20"" (1) WRAPPER 24"" X 24"" (16) GAUZE SPONGES 2"" X 2"" 8PLY (1) TRAY HALF SHALLOW(12) COTION TIP APPLICATOR 6"" WOOD (2) GLOVE SKY NITRILE PF BLUE MED(18) GAUZE SPONGES 4"" X 4"" 12PLY (1) SMALL DRAPE W/ADH APERTURE POUCHProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Hip & Knee replacement pack; 900-2614; contains(1) CAUTERY TIP POLISHER UF(1) BAG SUTURE FLORAL(1) TUBE SUCTION CONNECT Y." X 12′ UF(1) TABLE COVER REINFORCED 50" X 90" UF(1) MAYO STAND COVER REINFORCED UF(5) TOWELS ABSORBENT 15" X 20" UF(2) DRAPE SHEET 70" X 100" L/F(5) LAP SPONGE PREWASH 18" X 18" XRD LIF(1) SKIN STAPLE 35 WIDE LIF(1) MAYO TRAY LARGE(1) TOP DRAPE WITH ADHESIVE 100" X 50" SMS STD L/F(1) BULB SYRINGE 60cc(1) UTILITY BOWL 16oz(1) UTILITY BOWL QUART 32oz(1) INCISION DRAPE 23" X 17"(1) SKIN MARKER WITH RULER(1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21(1) YANKAUER SUCTION TUBE WITHOUT VENT UF(1) MERLING SKIN PREP APPLIC. 39ML UF(1) BLADE SURGICAL# 10 STAINLESS STEEL(1) SHEET SPLIT WITH ADHESIVE 108" X 77" UF(1) *GLOVE# 7.5 SURGEON NEUTRALON LATEX(1) * GLOVE # 8 SURGEON NEUTRALON LATEX(1) *GLOVE# 8.5 SURGEON NEUTRALON LATEX(3) GOWN IMPERVIOUS EXTRA REINFORCED XL LIF(1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP(4) UTILITY DRAPE WITH TAPE UF(1 0) GAUZE SPONGE 4" X4" 16PL Y XRD LIF(2) BANDAGE ELASTIC WITH VELCRO 6" X 5yds(1) BLADE SURGICAL# 20 STAINLESS STEEL(2) LITE GLOVE UF(1) STOCKINETIE IMPERVIOUS 12" X 48"(1) CAUTERY PENCIL ROCKER SWITCH UF(1) BANDAGE ESMARK 6" X 9yds UFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz.(2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE(1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF(1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK(1) MAYO STAND COVER REINF. LIF(1) EYE DRAPE LIF(1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY PACK – ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F( 1) NEEDLE ULTRA VERES 120MM LIF( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF(1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III(1) MAYO STAND COVER REINFORCED LIF(5) SPONGE LAP PREWASH 18" X 18" XRD LIF( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF( 1) BOWL UTILITY 16oz. LIF(1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF(1) DRAPE LASER CAMERA W/EL 6" X 96" LIF(1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF(4) DRAPE UTILITY WITH TAPE LIF(4) TOWELS ABSORBENT 15" X 20" LIF(1) DRAPE ENDOSCOPY 100" X 123%" X 77" WITH TROUGHS L/F(2) SHEET DRAPE 42" X 57" SMS LIF(1) BLADE SURGICAL #11 STAINLESS STEEL( 1) TIME OUT BEACON NON WOVEN ST L/F(6) GAUZE SPONGE 2" X 2" 4PL Y LIF( 1) BLADE SURG. #15 CARBON STEEL( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF(1) TABLE COVER REINFORCED 50" X 90" L/FProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – GENERAL PACK – CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF(1) MAYO STAND COVER REINFORCED LIF( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF(2) UTILITY BOWL 16 oz. LIF(1) GLASINE BAG PLAIN( 1) SUTURE BAG FLORAL(4) DRAPE UTILITY WITH TAPE LIF( 1) TABLE COVER REINFORCED 50" X 90" LIF(1) SURGICAL BLADE# 10 STAINLESS STEEL( 1) SURGICAL DURAPREP SOLUTION 26mL LIF( 1) LAPAROTOMY T DRAPE STD SMS(2) DRAPE SHEET 41" X 58" SMS LIF(2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF(1 0) GAUZE 4"X 4" X 4 PLY( 1) CAUTERY TIP POLISHER LIF(5) LAP SPONGES PRE-WASH XRD LIF( 1) CAUTERY PENCIL ROCKER SWITCH LIF(1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF( 1) TUBE SUCTION CONNECT. 3/16" X 12′ LIF( 1) SURGICAL BLADE# 15 CARBON STEEL( 1) CONTAINER SPECIMEN 4 oz. WITH LID & LABELProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY CHOLE PACK – (6) TOWELS ABSORBENT 15" X 20" LIF(1) MAYO STAND COVER REINFORCED L/F(1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF(1) SURGICAL BLADE #11 CARBON STEEL(1) TUR Y SET; 2LEAD L/F(4) DRAPE UTILITY WITH TAPE LIF(1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT)(1) ULTRA VERES NEEDLE 120mm(1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF(1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78"(2) DRAPE SHEET 41" X 58" SMS(2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF(10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F(5) LAP SPONGE PREWASH XRD LIF(1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF(1) TUBE SUCTION CONNECT. 3/16" X 12′ LIF(1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT)(1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF(1) SURGICAL DURAPREP SOLUTION 26ML LIF(1) TABLE COVER REINFORCED 50" X 90" LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CESAREAN PACK – (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF(1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78"(1) UTILITY BOWL 32 oz. (10) LAP SPONGES PRE-WASHED XRD LIF(2) PAD OBSTETRICAL XLGE (1) BABY BEANNIES(1) MAYO STAND COVER REINFORCED L/F (1) DRAPE SHEET 41" X 58" SMS LIF(1) TUBE SUCTION CONNECT. X" X 12′ L/F (1) EAR ULCER SYRINGE 2oz. LIF(1) RECEIVING BLANKET 100% COTION (1) YANKAUER SUCT TUBE WITHOUT VENT L/F(1) UMBILICAL CORD CLAMP (2) WRAPPER 20"X 20"(1) DRESSING ISLAND 4" X 10" (1) SCALPEL# 10 WITH HANDLE S/S(1) SCALPEL# 20 WITH HANDLE (1) TABLE COVER REINFORCED 50" X 90" L/F(1) MAYO TRAY SMALL (1) MUCUSTRAP 20cc 1 OFr.(2) GOWN LGE SMS IMPERVIOUS REINFORCED (1) SURGICAL DURAPREP SOLUTION 26mL L/FProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Customed Laparotomy Pack ; convenience pack include multiple components: drape laparot.; gown; absorbent towel; scrub; stck sponges/ gauzes; table cover; drape sheet; suture bag; duraprep surgical solution; cloth huck towels; utility bowls; suction tube; scalpel; Mayo Tray; Mayo Cover; & lite gloves.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ORTHOPEDIC PACK I (2) CUSTOMED; 900-2503; contains:(2) TOWELS ABSORBENT 15" X 20" LIF(1) COVER MAYO STAND REINFORCED L/F( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF(1) DRAPE % ECONOMY 53" X 77" LIF(4) DRAPE UTILITY WIT APE LIF(1) BAG SUTURE FLORAL LIF(1) SHEET SPLIT W/ADHES 1 08" X 77" LIF(1) COVER TABLE REINFORCED 50" X 90" LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PREMIUM ARTHROSCOPY PACK – CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF(1) IMPERVIOUS STOCKINETTE(3) STRIPS TAPE 24" X 4"(1) DRAPE U WITH TAPE SPLIT(2) TOWELS ABSORBENT 15" X 20" LIF(1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS(1) GOW SURG. REINFORCED LARGE TOWEL/WRAP(1) TABLE COVER REINFORCED 50" X 90" LIF(1) MAYO STAND COVER REINFORCED LIF(1) CONTAINER SPECIMEN 4oz WITH LID & LABEL(1) TUBE SUCTION CONNECT. }4" X 12′ LIF(1) SURGICAL BLADE #11 CARBON STEEL(1 ELASTIC BANDAGE 6" X 5 YRD. L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PLASTIC SURGERY PACK – LABEL SAMPLECONTENTS:(2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF(10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90"(1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL(1) DRAPE HEAD WIT APE 44" X 26" LIF (30) COTION TIP APPLIC 6" WOOD LIF(1) PVP PAINT 8" STICK SPONGE(1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ANGIOGRAPHY PACK – (1) LINE H.P. 1200 PSI 48" M/F(1) ANG. FEMORAL DRAPE WITH POUCH UF(1) PLATFORM TRAY LARGE(3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF(1) TABLE COVER REINFORCED 50" X 90" LIF(2) BAG BAND RUBBAN & TAPE UF(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF(5) ABSORBENT TOWELS 15" X 20" LIF(1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF(1) SURGICAL DURAPREP SOLUTION 6ML LIF(1) SAFETY SCALPEL #11 STAINLESS STEEL(2) GOWN STANDARD SMS LARGE VELCRO NECK(1) MANIFOLD WITH CONTROL SYRINGE(1) NEEDLE 18G X 2% AMC/4(2) UTILITY BOWL 16oz UF(2) CLOTH HUCK TOWEL BLUE(2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF(2) MEDICINE CUP 2oz LIF(30) GAUZE SPONGE 4" X 4" 16PL Y(1) NEEDLE HYPODEMIC 18G X 1 ~(4) TOWEL CLAMP(2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF(1) HALSTED MOSQUITO CVD 5" SERRAT(2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F(2) NEEDLE HYPODERMIC 22G X 1EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CIRUGIA CARDIOVASCULAR – CASE CART -(1) CIRUGIA CARDIOVASCULAR (PREPARACION)(1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE)(1) CIRUGIA CARDIOVASCULAR (INDUCCION)(1) OPEN HEART TRAYEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE(1) DRAPE UNDERBUTIOCK WITH POUCH(1) TOWELS ABSORBENT 15" x 20" UF(2) LEGGINS W/7" CUFF 30" X 42"(1 ) TABLE COVER REINFORCED 50" X 90" UF(1) DRAPE ABDOMINAL WITH TAPE UFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY PACK – (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF(1) DRAPE ENDOSCOPY 1 00" X 123W’ X 77" WITH TROUGHS(1) MAYO STAND COVER REINFORCED LIF(4) TOWEL ABSORBENT 15" X 20" LIF(4) DRAPE UTILITY WITH TAPE LIF(5) GAUZE SPONGE 2" X 2" 4PL Y(1) CORD LAPAROSCOPY FOOD SWICHING MONOPOLAR(1) SCALPEL WEIGHTED SAFETY #11(1) SOLUTION SURGICAL DURAPREP 26ml UF(1) TABLE COVER REINFORCED 50" X 90" LIF(2) LITE GLOVE UF(1) SUTURE BAG FLORAL UF(1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF(1) UTILITY BOWL 32oz.(2) SHEET DRAPE 42" X 57" SMS(1) DRAPE LASER CAMERA W/EL 6" X 96" LIF(5) TAPE TEGADERM 2 3/8 X 2 o/. UF(5) LAP SPONGE PREWASH 18" X 18" XRD L/F(2) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE(1) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE TOWEL/WRAPEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS(3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV(1) DRAPE SHEET 42" X 57" SMS(4) DRAPE UTILITY WITH TAPE LIF(1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF(1) PENCIL CAUTERY HAND SWITCHING LIF(1) TUBE SUCTION CONNECT "Y-1" X 12′ LIF(1) FRAZIER WITH CONTROL VENT & OBTUR 10F LIF(2) LITE GLOVE LIF(1) BOWL UTILITY 32oz LIF(2) BOWL UTILITY 16oz LIF(10) LAP SPONGE PREWASH XRD LIF(1) SOLUTION SURGICAL DURAPREP 26ML LIF(3) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF(1) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK UF(1) SYRINGE 5CC WITH NEEDLE 21G X 1% LUER LOCK UF(2) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF(1) NEEDLE HYPODERMIC 18G X 1 %(2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR UF(1) COVER MAYO STAND REINFORCED LIF(1) COVER TABLE 44" X 90"(1) MAYO TRAY SMALL(2) ABSORBENT TOWEL 15" X 20" UF(1) BOWL WITH LID PLASTIC 80ozEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – UNIVERSAL PACK – (1) UTILITY BOWL 16oz.(1) NEEDLE SPINAL ANEST. 22G X 31!2(1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF(2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF(1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF(1) NEEDLE HYPODERMIC 20G X 1 1!2(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII(1) SPLIT SHEET WITH ADHESIVE 108" X 77" SMS STD LIF(1) DRAPE % ECONOMY 53" X 77" UF(2) TOWEL ABSORBENT 15" X 20" UF(4) DRAPE UTILITY WITH TAPE LIF(1 0) GAUZE SPONGES 4" X 4" 12PL Y(4) TOWELS CLOTH HUCK BLUE(1) TABLE COVER REINFORCED 50" X 90" UF(1) SCALPEL WITH HANDLE #11(3) PK. CLOSURE SKIN W’ X 4" STERI STRIP UF(1) SKIN MARKER WITH RULER(1) DENTURE CUP 8oz WITH LID(1) NEEDLE HYPODERMIC 25 X 1 1!2(1) STOCKINETTE IMPERVIOUS 14" X 48"(2) TIP ABSORB. APPLICATOR STICK SPONGE(1) TRAY ORGANIZER FULL DEEP(1) TRA 2/COMPARTMENT(1) RULER L/FProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – LAPAROSCOPY PACK I (4) CUSTOMEDCONTENTS: (1) TOWEL ABSORBENT 15"" X 20"" LIF (2) LEGGINGS W/7" CUFF 30"" X 42"" LIF (1) DRAPE UTILITY WITAPE L/F(1) SUTURE BAG FLORAL LIF(1) SHEET T LAPAROSCOPY SOFT 97"" X 96"" X 36 LIF""(1) TABLE COVER REINFORCED 44"" X 78"" L/FProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Customed Major Laparotomy Pack ; convenience pack include multiple components: Mayo stand cover; absorbent towel; bag suture; drape; suction tube; lite glove; gauze/sponges; drape; surgical blades; utility bowls; towels; tube suction; cautery tip; gown; and labels.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – FACE PACK AESTHETIC SURGERYAESTHETIC SURGERYCONTENTS: (15) APPLICATOR COTION 6"" WOOD(60) GAUZE SPONGE 4"" X 4"" 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF(8) TOWELS CLOTH HUCK BLUE LIF(2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (6) BLADE #15 CARBON RIB(1) SHEET ENT SPLIT 110"" X 77"" SMS L/F (3) *Pr. GLOVE PERRY SURG # 7.5 LATEX(5) SPONGE LAP PREWASH 18"" X 18"" XRD LIF (1) COVER TABLE REINFORCED 50"" X 90"" LIF (2) COTTON BALL MED(3) *Pr. GLOVE PERRY SURG # 7 LATEX (1) DRAPE INST. MAGNETIC 10"" X 16"" L/F(2) NEEDLE 30G X 1 DISP LIF(1) MARKER SKIN WITH RULER LIF(4) LABELS FOR SKIN MARKERS 1.25 X Y2(1) COUNTER NEEDLE AND BLADE 15C FOAM I MAG STRIP LIF (2) GOWN SOFT SMS STD X-LGE SET IN SLEEVE LIF(1) RULER 6"" FLEXIBLE(1) BAG ZIP LOCK 6"" X 10"" PLASTICProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Tummy Pack MRT; code 900-2657; contains:(2) GOWN SOFT SMS STD XLGE SET IN SLEEVE( 1) CAUTERY PENCIL PUSH BOTTOM( 1) NEEDLE ULTRACLEAN 1"(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG( 1) BOWL UTILITY QUART 32oz(1 ) MAYO STAND COVER REINFORCED(1 ) TABLE COVER REINFORCED 50" X 90"(1 ) DRAPEBREASTICHEST SMS( 1) RULER 6" CLEAR(6) TOWEL CLOTH HUCK C (BLUE)(2) TOWELS ABSORBENT 15" X 20"( 1) TUBE SUCTION CONNECT ~" X 12′( 1) DENTURE CUP 8oz WITH LID(2) SKIN MARKER INK WITH 8 LABEL(2) LITE GLOVESProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – OB PACK -(1) BABY BLANKET PRINTED(1) BABY BEANIES(1) TABLE COVER REINFORCED 50" X 90" LIF(2) LEGGINS W/7" CUFF 30" X 42" LIF(1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF(3) TOWEL ABSORBENT 15" X 20" LIF(1) DRAPE SHEET 41 " X 58" SMS LIF(2) PAD OBSTETRICAL X-LARGE LIF(1) RECEIVING BLANKET 100% COTTON(1) PVP SCRUB 8" STICK SPONGE(1) FEEDING TUBE BFR; 15" LONG LIF(1) BOWL PLASTIC 80oz WITH LID(1) CORD UMBILICAL CLAMP(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF(1) SYRINGE 20cc SLIP TIP LIF(1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF(1) NEEDLE HYPODERMIC 18G X 1%(1) NEEDLE HYPODERMIC 22G X 1%(20) GAUZE SPONGE 4" X 4" 16PL Y(1) EAR ULCER SYRINGE 2oz LIF(1) DRAPE ABDOMINAL WITH TAPE 40" X 54" LIF(2) GLOVE MED FREETOUCH VYNIL POWDER FREE(1) WRAPPER 24" X 24" L/F(1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL/WRAP LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PERl GYN PACK (1) TABLE COVER 44" x 90"(2) LEGGINS W/7" CUFF 30" x 42"(1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15" X 20"(10) GAUZE SPONGE 4" X 4" 16PLY (2) DRESSING NON ADH TELFA 4" X 3"(1) ROBINSON RED CATHETER 14FR. (1) UNDERBUTTOCK DRAPE WITH POUCHEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PREMIUM UROLOGY PACK – CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH.(2) ABSORBENT TOWELS UF(1) MAYO STAND COVER REINFORCED UF(1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF(1) GOWN SURG. REINFORCED LARGE T/WRAP(1) UTILITY BOWL 32 OZ.(1) TUBE SUCTION CONNEC. W’ X 12′ UF(1) TABLE COVER REINFORCED 50" X 90" UF(1) TUR Y SET 81 "2.1M REGULAR CLAM ST.(1) GOWN XL SMS IMPERVIOUS REINFORCED(1) SPECIMEN CONTAINER 4oz. W/LID & LABELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY CHOLECYSTECTOMY PACK – (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF(1) BLADE SURGICAL #11 STAINLESS STEEL (1) DRAPE SHEET 41 " X 58" SMS UF(10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) TUBE SUCTION CONNEC. 3/16" x 12′ UF(3) TOWEL ABSORBENT 15" X 20" UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIWRAP(1) TABLE COVER REINFORCED 50" X 90" UF (2) GOWN LARGE SMS IMPERV. REINFORCED(4) DRAPE UTILITY WITH TAPE UFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Face Pack FJG; code 900-3116; contains:(2) GOWN LARGE STANDARD SMS AAMIIII(2) TOWEL ABSORBENT 15" X 20"(1) COUNTER NEEDLE & BLADE 20C FOAM/MAG(1) COVER MAYO STAND REINFORCED(1) SHEET ENT SPLIT 11 0" X 77" SMS(1) COVER TABLE REINFORCED 44" X 78"(20) GAUZE SPONGE 4" X 4" 12PL Y(6) TOWEL CLOTH HUCK BLUE(1) PK. STRIP STERI CLOSURE W X 4"(2) CUP DENTURE 8oz TEAL WITH LID(1) SKIN MARKER WITH RULER(1) RULER(1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK(1) SHEET o/. DRAPE 60" X 77" REINFORCED(1) BLADE SURG. #15 CARBON STEEL(1) BLADE SURG. #10 CARBON STEEL(4) DRAPE UTILITY WITH TAPE(1) SYRINGE BULB 60CC(2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 P/F(2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 P/F(1) Pr. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 P/F(1) YANKAUER SUCTION TUBE WITHOUT VENT(1) TUBE SUCTION CONNECT%" X 12′(1) CAUTERY PENCIL PUSH BOTIOM HOLSTERProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CESAREAN PACK – -(7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0(1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL UTILITY QUART 32oz.(1) TUBE FEEDING 8Fr. 15" LONG(2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR(1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST.(1) SYRINGE 20cc W/0 NEEDLE LIL (1) SYRINGE EAR/ULCER 2oz.(1) BLANKET RECEIVING 100% COTION (1) CLAMP UMBILICAL CORD ST.(1) COVER TABLE REINFORCED 50" X 90"(1) SYRINGE 10CC W/0 NEEDLE L/LOCK(1) BOWL PLASTIC W/LID 80oz (2) GOWN XL SMS IMPERVIOUS REINFORCED(1) SHEET DRAPE 41" X 58" SMS (1) DRAPE C SECTION W/POUCH 102" X 121" X 78"(1) YANKAUER SUCTION TUBE W/0 VENT (1) WRAPPER 30" X 30"(15) SPONGE LAP PREWASH 18" X 18" XRD (1) TIME OUT BEACON NON WOVEN ST.(1) TUBE SUCTION CO NN ECT~" X 12′ (2) LIGHT SHIELD(1) GOWN SURG REINF LARGE T/WRAP(2) PK. STRIP STERI CLOSURE W’ X 4"(1) POLISHER CAUTERY TIP (1) DRESSING COMP OP 4" X 14"(1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULEREO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – FOLEY CATHETER KIT 1118FR.- CUSTOM EDCONTENTS:(1) WRAPPER 24" X 24" (1) LABEL ID PATIENT(1) TRAY ORGANIZER (1) PVP TRIPLE SWABSTICK IODOPHOR(2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM(1) TOWEL 3PL Y POLY 17" X 18" (2) SWABSTICK DRY COTTON(1) DRAPE 4" FENESTRATED 18" X 26" (1) CATHETER FOLEY 18FR; 2WAY SILICONE COATEDm SYRINGE 10ccWATERPREFIL UF (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF(1)SPECIMEN CONTAINER 4oz W/LID & LABELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – HIP PACK I (2); CUSTOMED; code 900-2504(1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP(1) MAYO STAND COVER REINFORCED(1) U-DRAPE 60" X 70" WITH TAPE SPLIT(1) STOCKINETTE IMPERVIOUS 12" X 48"(4) DRAPE UTILITY WITH TAPE(1) BAG SUTURE FLORAL(1) DRAPE HIP 89" X 128" REINFORCED WITH ADHESIVE(1) COVER TABLE REINFORCED 50" X 90"Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Shoulder Arthroscopy Pack; code 900-2719; contains:(1 0) GAUZE SPONGES 4 X 4 12PL Y(1) COBAN WRAP TAN 4 X 5yds(3) PAD ABDOMINAL 8 X 7.5(1) DRESSING 1 X 8 XEROFORM PETROLAT(1 0) GAUZE SPONGES 4 X 4 16PL Y XRD(1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 W(1) NEEDLE HYPODERMIC 22G X 1 W(1) SYRINGE 60ML W/O NEEDLE LUER LOCK(1) BLADE SURG. 11 CARBON STEEL(1) SKIN MARKER W/RULER(9) LABELS FOR SKIN MARKERS (4) PR GLOVE SURG. DERMA PRENE POWDER FREE(8) TOWELS CLOTH HUCK BLUE(2) U – DRAPE 60X 70 WIT APE SPLIT 6 X 21(1) SHEET 60 X 77 DRAPE REINFORCED(2) SOLUTION SURGICAL DURAPREP 26ML(3) TUBE SUCTION CONNECT (1) TABLE COVER REINFORCED 50 X 90(1) RULER(2) GOWN SURGICAL REINFORCED X-LARGE(1) GOWN SURGICAL RE INFORCED X-LARGE TOWEL/WRAP(2) TOWELS ABSORBENT 15 X 20(2) BAG PLASTIC 6 X 12 2ml(1) SHOULDER ARTHROSCOPY DRAPE(1) FILTER STRAW 5 MICRO(1) UTILITY BOWL 16oz(1) STOCKINETTE IMPERV 9 X 48(2) LITE GLOVEProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – OPEN HEART TRAY – PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE(3) DRESSING NON ADH TELFA 8 X 3 (2) BAG GLASSINE PLAIN(2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) COVER TABLE REINFORCED 50" X 90" LIF(1) NEEDLE HYPODERMIC 27G X ‘h" (4) COUNTER NEEDLE & BLADE 10c MAG/CLEAR(2) SYRINGE 20cc WITHOUT NDL LUER LOCK LIF (1) JAR 16oz 500cc GRADUATE MEASURE(2) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (2) PENCIL CAUTERY HAND SWITCHING LIF(1) MARKER SKIN RULER (2) BANDAGE ELASTIC 4" X 5yds LIF(2) POLISHER CAUTERY TIP LIF (2) BANDAGE ELASTIC 6" X 5yds LIF(2) SYRINGE BULB 60cc CLEAR (2) TUBE SUCTION CONNECT Y-t" X 12’ LIF(1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) NEEDLE BLADE/KNIFE 3.0mm(2) CONTAINER SPECIMEN 40z. WITH LID & LABEL (1) BLADE SHARP ALL ARROUND(1) BASIN EMESIS 10 IN 700cc (3) CATHETER 20FR ROB NEL RED RUB(3) BOWL UTILITY QUART 32oz LIF (2) CATHETER THORACIC 32FR STRAIGH(1) LABELS SET; HEPARINE; SALINE; ETC. (2) SAFETY SCALPEL #10 DISP(3) BASIN WASH ROUND 6QT (2) SAFETY SCALPEL #15 DISP(2) BOWL UTILITY 16oz L/F(1) WRAPPER 54" X 54" L/F(1) CONNECTOR Y 3/8" X 3/8" X 3/8"EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CARPALTUNNELLARGE – (1) TABLE COVER 50" X 90" REINFORCED LIF(1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF(1) UTILITY BOWL 32oz LIF(2) DRAPE SHEET 41 " X 58" SMS(1) BANDAGE GAUZE 4" STRETCH(1) NEEDLE HYPODERMIC 25G X 5/8"(1) STOCKINETTE 6" X 48" LIF(2) CLOTH HUCK TOWEL BLUE(1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP(1) GOWN SURGICAL REINF XL TOWEL/WRAP(1) NEEDLE HYPODERMIC 18G X 1 %"(10) GAUZE SPONGE 4" X 4" 16PLY XRD L.F(1) UTILITY BOWL 16oz LIF(1) ABSORBENT TOWELS 15" X 20" LIF(1) CAST PADDING(2) SURGICAL BLADE #15 STAINLESS STEEL(4) DRAPE UTILITY WITH TAPE L/F(1) SHEET EXTREMITY ABS. 125" x 85" SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF(1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF(1) TUBE SUCTION CONNECT. Y.!" X 12′ L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF(2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX (2) BLADE SURGICAL# 10 STAINLESS STEEL(1) BAG GLASSINE (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF(2) LITE GLOVE LIF (1) SPLIT SHEET W/ADHES 108" X 77" STD SMS UF(1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF(5) ABSORBENT TOWELS 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD LIF(2) DRAPE SHEET 70" X 100" STD SMS LIF (1) MAYO TRAY LARGE(2) * Pr. SURGEON NEUTRALON GLOVE #8% LATEX (1) STAPLE SKIN WIDE 35 ST. LIF(1) TOP DRAPE W/ADHES. 108" X 50" STD SMS LIF (1) BULB SYRINGE 60cc(2) BANDAGE ELASTIC 6" X 5"yds LIF (2) UTILITY BOWL 32oz(1) UTILITY BOWL 16oz LIF (1) SKIN MARKER WITH RULER(1) INCISE DRAPE ANTIMICROBIAL 23" X 17" LIF (2) ABDOMINAL PAD 8" X 7 W(1) U-DRAPE 60" X 70" WIT APE SPLIT 6" X 21′ (2) GOWN IMPERVIOUS REINFORCED XL(1) YANKAUER SUCTION TUBE WITHOUT VENT UF (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGEEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90"(2) TOWELS ABSORBENT 15" X 20"(1) MAYO STAND COVER REINFORCED(1) BABY BLANKET PRINTED(1 0) LAP SPONGES PREWASH 18" X 18" XRD(1) BOWL PLASTIC WITH LID 80oz.(1) BAG GLASSINE(2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR(1) CORD UMBILICAL CLAMP(2) LIGHT GLOVE(1) BOWL UTILITY 32oz(1) BOWL UTILITY 16oz(4) DRAPE UTILITY(1) TUBE SUCTION CONNECT. 1!4" X 12′(1) TIP CAUTERY POLISHER(1) MUCUSTRAP 20cc; 10FR.(2) DRAPE SHEET 41" X 58" SMS(2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE(1) PENCIL CAUTERY ROCKER SWITCH(1) ELECTRODE DUAL DEPRES./GROUNDPAD(1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78"(1) EAR ULCER SYRINGE 2oz(1) BABY BEANNIES(1) RECEIVING BLANKET 100% COTTON(2) SURGICAL BLADE #10 STAINLESS STEELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Open Heart Tray; Pack A; code 900-1196C; contains:(1) TABLE COVER REINFORCED L/Free(1) CARDIOVASCU.LAR INCISE DRAPE L/Free(2) 3/4 ABS. REINFORCED SHEET(1) PLASTIC SHEET(5) DRAPE SHEET SMS(18) CLOTH HUCK TOWELS Blue(4) CLOTH HUCK TOWELS White(1 0) ABSORBENT TOWELS L/Free(4) GOWN IMP. BREATHABLE LGE.(3) MAYO STAND COVER L/Free(2) IMPERV. STOCKINETTE(1) WRAPPER 54" X 54"(1) TRAY PLATFORM LGE(1) TABLE COVER HD L/Free(1) WRAPPER 24" X 24"Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Arthroscopy Pack;900-2609; contains:(5) LAP SPONGE PREWASH 18" X 18" XRD(1) SHEET ARTHROSCOPY T STD SMS WITH POUCH(3) STRIPS TAPE 24" X 4"(1) U-DRAPE 60" X 70" WITH TAPE SPLIT(4) TOWELS ABSORBENT 15" X 20"(1) MAYO STAND COVER REINFORCED(1) TUBE SUCTION CONNECT Y4" X 12′(2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds(10) GAUZE SPONGE 4" X 4" 16PLY XRD(1) MERLING SKIN PREP. APPLIC 39ML(1) CAST PADDING COTTON ROLL 2" X 4yds(1) SKIN MARKER WITH RULER(1) BLADE SURGICAL# 11 CARBON STEEL(1) GOWN SURG REINFORCED LGE TOWEL WRAP(2) GOWN XL SMS IMPERVIOUS REINFORCED(2) LITE GLOVE(1) STOCKINETTE IMPERVIOUS 12" X 48"(1) TABLE COVER REINFORCED 50" X 90"Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Breast pack TPSC; code 900-3431; contains:(1) GOWN LARGE STANDARD SMS AAMIIII(1) GOWN SOFT SMS STD. X-LARGE AAMIIII(4) TOWELS ABSORBENT 15" X 20" LIF(1) PENCIL CAUTERY PUSH BOTTOM LIF(1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F(1) TUBE SUCTION CONNECT X" X 12′ LIF(1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F(1) COVER MAYO STAND REINFORCED LIF(2) SKIN MARKER INK WITH 8 LABEL/TIME OUT RULER LIF(2) BOWL UTILITY QUART 32oz.(1) COVER TABLE REINFORCED 50" X 90" LIF(1) RULER LIF(4) DRAPE UTILITY LIF(2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF(1) DRAPE BREAST/CHEST SMS LIF(1) GAUZE KERLIX 4.5"X 4 1/8 YD 6PL Y L/F(2) LITE GLOVES(5) SPONGE LAP PREWASH 18" X 18" XRD LIF(1) SHEET DRAPE 42" X 57" SMS LIF(1) SHEET DRAPE 70" x 100" LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ORTHO IMPLANT SURGICAL PACK – (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21"(1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z"(1) TUBE SUCTION CONNECT. }4" X 12′ (1) DURAPREP SURGICAL SOLUTION 26ml(1) BAG GLASSINE (1) YANKAUER SUCTION TUBE WITHOUT VENT(2) LITE GLOVE (1) SPLIT SHEET WITH ADHES 1 08" X 77" STD SMS(2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE (1) STOCKINETTE IMPERVIOUS 14" X 48"(1) MAYO STAND COVER REINFORCED (1) INCISE DRAPE ANTIMICROBIAL 23" X 17"(5) ABSORBENT TOWELS 15" X 20" (1) GOWN IMPERV. EXTRA REINFORCED XL SMS TNI/RAP LEVEL IV(4) DRAPE UTILITY (1) CAUTERY PENCIL ROCKER SWITCH(5) LAP SPONGES PREWASH XRD (1) GOWN IMPERVIOUS REINFORCED SMS X-LARGE(2) DRAPE SHEET 70" X 100" STD SMS (1) TIME OUT BEACON NON WOVEN(1) STAPLE SKIN WIDE 35 ST. (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER(1) MAYO TRAY LARGE (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG(1) TOP DRAPE W/ADHES. 100" X 53" SMS (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL WRAP(2) BANDAGE ELASTIC 6" X 5"yds (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK(1) UTILITY BOWL 16oz (1) NEEDLE HYPODERMIC 18G X 1Y2(2) UTILITY BOWL 32oz (2) BLADE SURGICAL# 10 STAINLESS STEELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF(2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP(1 0) GAUZE SPONGE 4" X 4" 12 PLY(1) URINARY DRAINAGE BAG 2000ML ANTI-REFLUX LIF(1) TABLE COVER REINFORCED 44" X 78" LIF(1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS(3) TOWELS ABSORBENT 15" X 20" LIF(1) TUR Y SET 81"2.1m REGULAR CLAM ST.(1) TUBE SUCTION CONNECT Y4" X 12′ LIF(1) BAG SUTURE FLORALEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – 08 PAD PACK II (2;3)CUSTOMEDCONTENTS: (3) TOWEL ABSORBENT 15"" X 20"" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC 44"" X 65"" (1) DRAPE UNDERBUTTOCK W/POUCH (1) UMBILICAL CORD CLAMP(1) BABY BLANKET 30"" X 30"" POLY ABSOR.IMP. (1) PACKING VAGINAL XRD 4"" X 36"" 8PLY (10) GAUZE SPONGE 4"" X 4"" 16PLY XRD (1) DRAPE ABDOMINAL WITAPE 40"" X 54""(2) LEGGINS W/7" CUFF 30"" X 42"" (1) TABLE COVER REINFORCED 44"" X 78"" (2) PAD OBSTETRICAL XL (1) EAR ULCER SYRINGE 2oz.Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – BASIC PACK 1 (Ill) CUSTOMEDCONTENTS: (1) TABLE COVER REINFORCED 44"" X 78"" (4) DRAPE UTILITY WffAPE(2) TOWELS ABSORBENT 15"" X 20"" (1) SUTURE BAG FLORAL(1) DRAPE SHEET 42"" X 57"" SMS(1) SHEET :X 57"" X 63"" REINFORCED SMS (1) MAYO STAND COVER REINFORCEDProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Breast Pack BOD; code 900-3029; contains:(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill(2) TOWEL ABSORBENT 15" X 20"(1) PENCIL CAUTERY PUSH BOTTOM(1) SYRINGE BULB 60CC(1) TUBE SUCTION CONNECT%" X 12′(1) COUNTER NEEDLE/BLADE 20C FOAM/MAG(1) BOWL UTILITY QUART 32oz TURQ(1) COVER MAYO STAND REINFORCED(1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER(1) COVER TABLE REINFORCED 50" X 90"(1) CUP DENTURE 8oz TEAL WITH LID(1) RULER(6) TOWEL CLOTH HUCK BLUE(2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK(1) YANKAUER SUCTION TUBE WITHOUT VENT(1) DRAPE BREAST/CHEST(2) LITE GLOVEProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – REEMPLAZO DE RODILLA Y CADERACONTENTS:(6) TOWELS ABSORBENT 15"" X 20"" (I) PK. STRIP STERICLOSURE Y;"" X 4""(I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0(I) STOCKrNETTE IMPERV 14"" X 48"" (I) TIME OUT BEACON NON WOVEN (2) DRAPE U 60"" X 70""WI TAPE SPLIT 6"" X 21 "" (2) TUBE SUCTION CONNECT’/." X 12′(2) DRAPE INCISE ANTIMICROBIAL 23"" X 17"" (2) LIGHT SHIELD(I) NEEDLE SPINAL ANESTH 18G X 3 Y; (4) STR IPS TAPE 24"" X 4""(I ) GOWN IMP. XTRA REINF SMS XL T/W LEVEL (20)GAUZE SPONGES 4"" X 4"" 16PLY(3) DRAPE ‘!. ECONOMY 53"" X 77"" (I) DRAPE UNDERBUTTOCK W/POUCI-1 44"" X 35""(I) DRAPE TOP WIADHESIVE 108"" X 50"" STD SMS (I) COUNTER NEEDLE 60C FOAM STRIP/MAG STRIP (I) YANKAUER OPEN TIP CLEAR W/0 CIV (2) DRAPE SIDE 36"" X 77"" W/ADl-1.(I) SHEET SPLIT W/ADHES 108"" X 77"" STD SMS (I) SYRINGE 60ML UL W/0 NEEDLE (I) POLISHER CAUTERY TIP (I) NEEDLE BLUNT FILL 1 8G X I Y;(2) COVER TABLE BTC 77"" X I I 0""l-ID FULL COVERAGE (2) GLOVE SURG. DERMA PRENE #8 POWDER FREE(10) SPONGE LAP PREWASH 18"" X 18"" XRD (I) COVER MAYO STAND W/CSR 23"" X 54"" (I) BOWL UTILITY QUART 32oz. (3) CLAMP TOWEL(I) BOWL UTILITY PINT 16oz. (3) GOWN MICROCOOL IMP. XTRA LONG XL(3) BANDAGE ELASTIC 6"" X 5YRD WIVELCRO (I) MERLING SKrN PREP APPLIC.39ML (2) PADDING CAST SOFT ROLL 6 X 4YRD (I) MAYO TRAY LARGEProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – CYSTO TUR PACK BASIC CODE 900-2899.CONTENTS: (2) LEGGINGS W/7" CUFF 30"" X 42""(1) COVER TABLE REINFORCED 44"" X 78"" (2) TOWELS ABSORBENT 15"" X 20""(1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill(1) TUR CYSTO IRRIGATION SET 79"" SINGLE (1) TIME OUT BEACON NON WOVEN ST(1) BAG SUTURE FLORAL (1) UTILITY BOWL 32oz(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER(1) TURP CYSTO DRAPE WITH POUCH(1) GOWN IMPER EXTRA REINF LGE AAMI LEVEL Ill TOWEL & WRAPProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – ARTHROSCOPY PACK – (1) SURGICAL DURAPREP SOLUTION 26ML LIF(1) ESMARK BANDAGE(1 ) ELASTIC BANDAGE 6" X 5yds LIF(1) NEEDLE & BLADE COUNTER 20C FOAM/MAG(1) TUBE SUCTION CONNECTING W X 12′ LIF(1) SHEET EXTREMITY ABS. 125" X 85" SMS(1) DRAPE LASER CAMERA W/EL(3) TOWELS ABSORBENT 15" X 20" LIF(2) CONTAINER SPECIMEN 4oz. WITH LID & LABEL(1) BABY BLANKET IMP. POLY ABS. LIF(1) NEEDLE HYPODERMIC 20G X 1%"(10) GAUZE SPONGES 4" X 4" 16PLY(1) BLADE SURGICAL #11 CARBON STEEL(1) TABLE COVER REINFORCED 50" X 90" LIF(1) IMPERVIOUS STOCKINETTE(1) SHEET DRAPE 42" X 55" LIF(1) SUTURE BAG FLORAL LIF(1) U-DRAPE 60" X 70" WITH TAPE SPLIT(1) MAYO STAND COVER REINFORCED LIF(2) GOWN IMPERVIOUS REINFORCED SMS LARGE(4) STRIPS TAPE(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF(1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y(1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL & WRAPEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF(2) TOWELS ABSORBENT 15" X 20" UF(1) TOP DRAPE WITH ADHESIVE STD SMS(1) CATHETER NELATON ROB. 14FR.(2) GOWN IMPERVIOUS EXTRA REINFORCED XL(1) UNDERBUITOCK DRAPE WITH POUCH(2) LEGGINS WITH 7" CUFF 30" X 42"(1) TABLE COVER REINFORCED 44" X 78" UF(1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF(1) TOWEL ABSORBENT 15" X 20" UF(2) LEGGINGS W/7" CUFF 30" X 42"(1) TABLE COVER REINFORCED 44" X 78" UF(1) DRAPE UNDERBUTTOCK WITH POUCHEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – IMPLANTE DE ORTHOPEDIA – ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF( I) TUBE SUCTION CONNECT \14" X 12′ LIF ( I) BAG GLASSINE LIF(2) LITE GLOVE LIF (2) TABLE COVER 50" X 90" REINFORCED LIF( I) MAYO STAND COVER REINFORCED LIF (5) TOWEL ABSORBENT 15" X 20" LIF(4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 70" X I 00" LIF(5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F ( I) MAYO TRAY LARGE LIF( I) DRAPE TOP WITH ADHESIVE LIF ( I) SKIN STAPLE 35 WIDE LIF( I) BULB SYRINGE 60cc LIF ( I) UTILITY BOWL 16oz L/F(2) UTILITY BOWL 32oz L/F ( I) INCISION DRAPE 23" X I 7" L/F(I) SKIN MARKER WITH RULER LIF ( I) U-DRAPE 54" X 72" W/TAPE SPLIT 6" X 2 1" LIF(2) ABDOMINAL PAD 8" X 7.5" L/F ( I) YANKAUER SUCTION TUBE W/0 VENT L/F(I) DURAPREP SURGICAL SOLUTION 26ML LIF ( I) SURGICAL BLADE # 10 STAINLESS STEEL(I) SPLIT SHEET W/ADH 108" X 77"" STD SMS LIF ( I) IMP. STOCKINETTE LIF(I) *Pr. SURGEON NEUTRALON GLOVE #7 ~ LATEX ( I) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX(I) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX (I) SURGEON GOWN REINF. T/WRAP X-LARGE LIF(2) IMP. GOWN REINFORCED X-LARGE SMS LIF (I) PENCIL CAUTERY ROCKER SWITCH LIF(I) SURGICAL BLADE #20 STAINLESS STEELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – DRESSING CHANGE – CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING TEGADERM 3 Y2 X 4 Y2( I) MASK PROCEDURAL YELLOW 80MM HG L/F (4) GAUZE 4" X 4" 4PLY( I) ALCOHOL PREP PAD MED ( I) CI-ILORASCRUB SWABSTICK 1.6( I) LABELCAUTION ( I) DRAPE NON FENESTR. 18" X 26" UF( I) TAPE TRANSPORE :Y. X 18 LIF ( I) WRAPPER 20" X 20"EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – CESAREAN PACK – (1) BABY BLANKET IMP. 30" X 30" POLY ABS.(1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF(1) DRESSING ISLAND 4" x 10"(1) CESAREAN DRAPE 71" x 125" LIF(2) GOWN SURG REINFORCED LARGE TOWEL/WRAP(10) LAP SPONGES PREWASH XRD LIF(1) BABY BEANNIES(1) SCALPEL #10 WITH HANDLE STAINLESS STEEL(1) DRAPE SHEET 42" X 57" SMS(1) EAR ULCER SYRINGE 2oz. UF(1) RECEIVING BLANKET 100% COTTON(1) SCALPEL #20 WITH HANDLE(1) DURAPREP SURGICAL SOLUTION 26ml UF(2) ABSORBENT TOWEL 15" X 20" L.F(2) LITE GLOVES UF(1) BOWL WITH LID PLASTIC 80oz.(1) TABLE COVER REINFORCED 44" x 78" LIF(1) UTILITY BOWL 32oz(2) PAD OBSTETRICAL X-LARGE ST.(1) WRAPPER 30" X 30" LIF(1) MAYO STAND COVER REINFORCED LIF(1) TUBE SUCTION CONNECT Y." X 12′ UF(1) MUCUSTRAP 20cc 1 OFR(1) YANKAUER SUCTION TUBE WITHOUT VENT UF(1) UMBILICAL CORD CLAMPEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – UROLOGY PACK – (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV(1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F(1) TUR Y SET; 81 "2 .1M REGULAR CLAM(1) TABLE COVER 44" x 90" (1) DRAPE LITHO 11 0" X 63" WITH POUCH /LEGGING FEN(1) TUBE SUCTION CONNECT. Y." X 12′ LIF (1) WASH BASIN ROUND 6QT(1 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (1) BAG URINARY DRAINAGE 2000ml ANTI-REFLUX LIF(1) DRAPE LASER CAMERA W/EL UF (1) SYRINGE 1 Occ W/0 NDL LUER LOCK UF(1 ) UTILITY BOWL 32oz. (1) GEL SYRINGE 10cc PREFILLED(5) SPECIMEN CONTAINER 4oz. W/LID & LABEL L/F (1) WRAPPER 20" X 20" L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Customed O.B. Pack convenience pack include multiple components: set up cover; absorbent towel; ear ulcer syringe; pad; umbilical cord clamp; wash basin; baby blankets; table cover; gauze sponge; syringe 10CC w/o needle & 10CC with needle; feeding tube; drape; legging with cuff; underbuttock drape; gown; container with lid; mayo tray; receiving blanket; & baby beannies.EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – HIGADO & PANCREA PACK – (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT VENT(4) DRAPE UTILITY WITH TAPE (6) TOWELS CLOTH HUCK BLUE(1) SHEET DRAPE 41 " X 58" SMS (1) MAYO TRAY LARGE(1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE INCISE ANTIMICROBIAL 23" X 17"(1) DRAPE BARIATRIC (1) BLADE SURGICAL #10 STAINLESS STEEL(1) CUP SPECIMEN WITH CAP 4oz (1) BLADE SURGICAL #15 STAINLESS STEEL(30) LAP SPONGE PREWASH 18" X 18" XRD (1) STRIP STERI CLOSURE W X 4"(1) POLISHER CAUTERY TIP (1) NEEDLE ECLIPSE 22 X 1 Y2(4) TOWEL ABSORBENT 15" X 20" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK(2) LITE GLOVE (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER(1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR (1) FORCE TRIVERSE(1) SYRINGE BULB 60CC (1) BLADE EXTENDED ELECT. 16.51cm(2) TUBE SUCTION CONNECT Y." X 12′ (2) CHLORAPREP 26ML APPLICATOR TEAL(1) TABLE COVER BTC 77" X 110" HD FULL COVERAGEProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – C – BIRTH PACK II {2)CUSTOMEDCONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4) TOWEL ABSORBENT 15"" X 20"" LIF(2) GOWN XLGE SMS IMPERVIOUS REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF(1) BLANKET BABY 30"" X 30"" POLYABS IMPERVIOUS LIF (1) SYRINGE EAR/ULCER 2oz LIF(2) PAD OBSTETRICAL X-LARGE(1) BOWL WITH/LID PLASTICS 80oz LIF (1) CLAMP UMBILICAL CORD LIF(1) BAG SUTURE FLORAL LIF(1) DRAPE C-SECTION W/POUCH 102"" X 121"" X 78"" LIF (1) COVER TABLE REINFORCED 50"" X 90"" LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF(1) MAYO STAND COVER REINFORCED LIF(1) OPHTALMIC DRAPE WITH POUCH LIF(2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF(10) COTTON TIP APPLICATOR 6" WOOD(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF(2) NEEDLE HYPODERMIC 18G X 1 Y."(1) NEEDLE HYPODERMIC 25G X 5/8"(2) EYE PAD 2 1/8 X 2 5/8 UF(5) EYE SPEAR MICRO SPONGE(2) LITE GLOVE LIF(1) CABLE BIPOLAR(1) EYE SHIELD UNIVERSAL(1) OPHTALMIC PENCIL BIPOLAR(1) IV ADM. SET 15 DROPS 106" LONG L/F(1) TABLE COVER REINFORCED 50" X 90" UF(1) KNIFE/BLADE MIN. EDGE ROUND(1) KNIFE 15 5.0 CONTROLLED(1) PLASTIC TRAY 3/COMPARTMENT(1)KNIFE 3.2MM ANGLE BEVEL UP(1) CYSTOTOMO IRRIG. 25GA X5/8(1) MAYO TRAY LARGE(2) GOWN STANDARD LARGE SMS STD VELCRO NECK(1) PVP PAINT 8" STICK SPONGE(1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Urology Pack; 900-2510; package contains:(2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF(10)GAUZE SPONGE 4" X 4" 12PL Y (1) GOWN XL SMS IMPERVIOUS REINFORCED UF(1) TUR Y SET 81 " 2.1M REGULAR CLAM (1) GOWN SURG REINFORCED LGE TOWEL & WRAP(1) TUBE SUCTION CONNE 1/4 X 12′ UF (3) GEL SYRINGE 10cc PREFILLED(1) TABLE COVER REINFORCED 44 X 78(1) SYRINGE 60ML LUER LOCK W/O NDL UFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – O.R. TOWELS- CUSTOMED-(6) TOWELS CLOTH HUCK BLUE( I) WRAPPER 20" X 20EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY OB GYN PACK – (1) DURAPREP SURGICAL SOLUTION 26ML LIF(1) SHEET T LAPAROSCOPY SMS LIF(2) DRAPE UTILITY WITH TAPE LIF(1) DRAPE SHEET 41" X 58" SMS LIF(4) ABSORBENT TOWELS 15" x 20" LIF(1) PVP TRIPLE SWABSTICK IODOPHOR(1) DRAPE LASER CAMERA W/EL 6" X 96"(1) TUBE SUCTION CONNECT.%" X 12′ LIF(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF(1) SURGICAL BLADE #11 CARBON STEEL(1) TABLE COVER 44" X 78" REINFORCED LIF(1) TEGADERM TRANS DRESSING 6" X 8"(2) LEGGINS WITH 7" CUFF 30" X 42"(10) GAUZE SPONGES 4" X 4" 12PLY XRD(1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX(1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF(1) TUR CYSTO IRRIGATION SET 79"(1) FOLEY CATHETER 16FR 2WAY; 5CC(2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF(2) GOWN IMPERVIOUS EXTRA REINF XLG LIF(1) TROCAR ENDO. XCEL DILATING TIP 5MM (K5LT)(1) PNEUMO INSUFLAT NEEDLE 150MM LUER LOCK LIF(1) CEFAZOLIN RED LABEL(1) GENTAMICIN GREEN LABEL(1) AZUL DE METILENO LABEL(1) HEPARINE WHITE LABEL(1) LIDOCAINE YELLOW LABELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – KNEE ARTHROSCOPY PACKCONTENTS:(1) TOWEL ABSORBENT 15"" X 20"" L/F (10) GAUZE SPONGE 4"" X 4"" 16PLY(1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z(1) U-DRAPE 60"" X 70"" WITH TAPE SPLIT (1) SKIN MARKER INK W/8 LABEL(2) TUBE SUCTION CONNECT. W X 12′ LIF (1) CAST PADDING SOFT ROLL 6 X 4yds L/F(2) BANDAGE ELASTIC 6"" X 5yds L/F (4) STRIP TAPE 24"" X 4"" LIF(1) Pk. STERI STRIP CLOSURE Y:z"" X 4"" LIF (1) SHEET ARTHROSCOPY ""T"" STD SMSW/POUCH L/F (5) LAP SPONGE PREWASH 18"" X 18"" XRD LIF (1) NEEDLE SPINAL ANESTHESIA 18G X 3% LIF (1) SYRINGE 10cc W/0 NDL L/LOCK LIF(1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) GOWN IMPERV. XTRA REINF. LGE TIWRAP (1) MAYO STAND COVER REINFORCED LIF(2) NEEDLE HYPODERMIC 25 X 1Y:z LIF(1) TIME OUT BEACON NON WOVEN ST. LIF(1) STOCKINETTE IMPERV. 14"" X 48"" LIF (1) TABLE COVER REINF. 50"" X 90"" LIF (1) SCALPEL WEIGHTED SAFETY #11(1) SAFETY GLIDE NEEDLE 21G X 1%(1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IVProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – MINOR LAPAROTOMY PACK – (1) DRAPE T LAPAROTOMY(1) BAG SUTURE FLORAL LIF(4) DRAPE UTILITY WITH TAPE LIF(1) TABLE COVER REINFORCED 50" X 90" LIF(1) MAYO STAND COVER REINFORCED LIF(4) TOWELS ABSORBENT 15" X 20" LIF(2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE(1) DRAPE% ECONOMY 53" X 77" LIF(1) CAUTERY PENCIL ROCKER SWITCH(1) UTILITY BOWL 16oz(2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAREO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY GYN PACK – (1) TABLE COVER REINFORCED 44" X 78"(1) LAPAROSCOPY SHEET "T" SMS(3) TOWELS ABSORBENT 15" X 20"(1) SURGICAL BLADE#11 STAINLESS STEEL(1) MAYO STAND COVER REINFORCED(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK(2) LEGGINS WITH 7" CUFF 30" x 42"(1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35"(4) DRAPE UTILITY WITH TAPE(2) GOWN IMPERVIOUS REINFORCED LARGE SMS(1) CONNECTING TUBING 3/16" X 12"EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – ORTHOPEDIC PACK BASICCODE 900-2830.CONTENTS: (3) TOWELS ABSORBENT 15"" X 20""(1) COVER MAYO STAND REINFORCED(1) U-DRAPE 60"" X 70"" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53"" X 77""(4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL(1) SHEET SPLITW/ADHES 108"" X 77"" STD SMS (1) COVER TABLE REINFORCED 50"" X 90""(1) STOCKINETTE IMPERVIOUS 14"" X 48"" (1) TIME OUT BEACON NON WOVEN(1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill(1) POLISHER CAUTERY TIP(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLIBLADE 20C FOAM/MAG(1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER(1) GOWN IMPERVIOUS EXTRA REINFORCED LGE T/WRAP AAMI LEVEL Il(1) BAG GLASSINE PLAIN(1) ELECTRODE DUAL DEPRESProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – ACDFPACKSURGICAL CENTER; CODE 900-2917.CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF(4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF(3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF (3) TOWELS ABSORBEN 15"" X 20"" UF(1) TABLE COVER REINFORCED 50"" X 90"" L/F (1) MAYO STAND COVER REINFORCED LIF(2) DRAPE o/.. 60"" X 76"" REINFORCED LIF (1)DRAPE THYROID 100"" X 142"" X 72"" LIF(1) FLUORO COVER 30"" X 30"" W/RUBBAND L/F (1) DRAPE INCISE IOBAN 13"" X 13""(2) LITE GLOVE LIF(2) TUBE SUCTION CONNECT. W X 12′ LIF (12) TOWELS CLOTH HUCK BLUE LIF(1) UTILITY BOWL 16oz LIF(10) GAUZE SPONGE 4"" X 4"" 16PLY XRD LIF(5) LAP SPONGE PREWASH 18"" X 18"" XRD LIF(1) SKIN MARKER W/RULER LIF(9) LABELS FOR SKIN MARKERS 1.25 X Y:! (1) RULER(1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF(2) SYRINGE 20cc W/0 NDL LUER LOCK LIF (2) SYRINGE 3cc W/0 NDL LUER LOCK LIF (1) BULB SYRINGE 60cc LIF(3) NEEDLE HYPODERMIC 18G X 1Y:! LIF (1) NEEDLE 30G X 1 DISP. L/F(1) NEEDLE SPINAL ANESTH 18G X 3W’ LIF (2) BLADE SURGICAL# 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN LIF(2) TAPE TEGADERM 2 3/8 ""X 2 o/.. ""L/F(2) MEDICINE CUP 2oz LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – ORTHOPEDIC SURGICAL PACKHOSPITAL SAN CRISTOBALCONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL(1) TUBE SUCTION CONNECT W’ X 1 2′ LIF(1) BAG GLASSINE (2) LITE GLOVE(1) TABLE COVER BTC 77"" X 11 0"" HD FULL COVERAGE LIF(1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT 1 5"" X 20"" LIF(4) DRAPE UTILITY WITH TAPE LIF ( 1 ) DRAPE SHEET 70"" X 100"" L/ F(5) LAP SPONGE PREWASH 18"" X 1 8"" XRD LIF (1 ) MAYOTRAYLARGE(1) DRAPE TOP WITH ADHESIVE 108"" X 50"" STD SMS LIF(1) SKIN STAPLER WIDE 35 LIF( 1) DRAPE INCISE ANTI M I CROBIAL 23"" X 1 7"" LIF (1) SKIN MARKER WITH RULER(1) U-DRAPE 60"" X 70"" WITH TAPE SPLIT 6"" X 2 1 "" LIF (1 ) PAD ABDOM INAL 8"" X 7""h."(1) YAUNKAUER SUCTION TUBE WITHOUT VENT LIF(1) SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1 ) BLADE SURG ICAL #10 STAINLESS STEEL(I) SPLIT SHEET WITH ADHESIVE 108"" X 77"" STD SMS LIF (2) *Prs. GLOVE # 8.5 SURGEON NEUTRALON LATEX( I ) *Pr. GLOVE# 8 SURGEON NEUTRALON LATEX( I ) GOWN SURG. REINFORCED XL TOWEL/WRAP AAMI Ill (3) GOWN XL SMS IM PERVIOUS REINFORCED AAM I III LIF ( I ) CAUTERY PENCIL ROCK ER SWITCH(2) *Prs. GLOVES SURG. # 8 POWDER(4) Prs. GLOVES SURG. 8.5Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL(1) UTILITY BOWL 32oz.(2) DRAPE SHEET 70"" X 100""(1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST.(1) STOCKINETTE 6 X 48""(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL WEIGHTED SAFETY# 11(1) BULB SYRINGE 60cc(1) DRAPE BEACH CHAIR SHOULDER ARTHROSCOPY (10) LAP SPONGE PREWASH 18"" X 18"" XRD(2) U-DRAPE 60"" X 70"" WITH TAPE SPLIT(2) DRAPE SHEET 41"" X 58"" SMS(1) STOCKINETTE IMPERVIOUS 14"" X 48"" (1) TABLE COVER REINFORCED 50"" X 90"" (1) COBAN WRAP TAN 4"" X 5yds(1) TIME OUT BEACON NON WOVEN(2) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL IV (2) MAYO STAND COVER REINFORCED(1) SKIN MARKER INK WITH 8 LABEL(1) TUBE CONNECTING SUCTION X"" X 12′ (1) MAYO TRAY SMALL( 1) CAMERA COVER W/ELAST.Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc "Customed – SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30"" X 30""(2) UTILITY BOWL 16oz (1) TRAY ORGANIZER FULL DEEP(1) SPECIMEN CONTAINER 4oz W/LID & LABEL (1) YANKAUER SUCTION TUBE WITHOUT VENT(5) LAP SPONGE PREWASH 18"" X 18"" XRD (1) BLADE SURG. #15 CARBON STEEL (2) NEEDLE & BLADE COUNTER 1Oc MAG/CLEAR (1) CAUTERY TIP POLISHER(1) BLADE SURG. #10 CARBON STEEL (2) LITE GLOVE(10) GAUZE SPONGE 4"" X 4"" 16PLY XRD (1) CAUTERY PENCIL ROCKER SWITCH (1) TIME OUT BEACON NON WOVEN STProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents." Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Laparotomy Pack; 900-2516; pack contains:( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM(4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF(4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION TUBE W/0 VENT LIF(2) COUNTER NDL /BLADE IOc MAG/CLEAR ( I) GOWN XL SMS IMPERV. REINFORCED LIF(5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) GOWN SURG REINFORCED. LGE T/WRAP LIF( I) TUBE SUCTION CONNECT W’ X 12′ LIF (2) LITE GLOVE LIF( 10) GAUZE SPONGE4" X 4" 16PLY XRD LIF (2) DRAPE SHEET 41" X 58" SMS LIF( I) CAUTERY TIP POLISHER LIF ( I) MERLING SKIN PREP APPLIC. 39ML LIF( I) UTILITY BOWL PINT 16oz LIF ( I) SKIN STAPLE 35 WIDE LIF( I) UTILITY BOWL QUART 32oz LIF( I) BLADE SURGICAL II CARBON STEEL( I) TRAY MAYO SMALL ( I) BLADE SURGICAL 20 CARBON STEEL( I) MAYO STAND COVER REINFORCED LIF ( I) DRAPE LAPAROTOMY 100" X 72" X 124" W/POUCHProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – FEMORAL ANGIOGRAPHY PACK – (1) TABLE COVER REINFORCED 50" X 90" UF(1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF(1) TOWEL ABSORBENT 15" X 20" UF(1) DRAPE ANGlO 75" X 145"(4) TOWELS CLOTH HUCK (BLUE) UF(3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF(1) IV ADM SET 15ML 1 06" LONG LIF(20) GAUZE SPONGE 4" X 4" 12PL Y LIF(1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF(1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF(2) MEDICINE CUP 2oz. CLEAR LIF(1) SCALPEL WEIGHTED SAFETY #11(2) CHLORASCRUB SWABSTICK 5.1 ML LIF(1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF(1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF(1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF(1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF(1) FORCEP ADS ON TISS. WITH TIP LIF(1) UTILITY BOWL 32oz LIF(1) UTILITY BOWL 16oz L/F(1) FORCEP KELLY STRAIGHT 5.5" LIF(1) MOSQUITO HALSTED CVD 5" LIF(1) TRAY ORGANIZER FULL DEEP LIF(1) SCISSOR MAYO 6.75 STRAIGHT LIF(1) HOLDER NEEDLE WEBSTER 4.75 LIF(1) GUIDEWIRE .035" X 150cm UF(1) TIME OUT BEACON NON WOVEN ST. UF(1) MAYO TRAY SMALL LIF(2) TOWEL CLAMP UF(2) BAG BAND RUBBAND & TAPE LIF(1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIFLABEL SAMPLE(1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF(1) NEEDLE 18G X 2 o/.i AMC/4(1) SKIN MARKER INK WITH/8 LABELEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – 0.B. PACK – -(1) TABLE COVER 44" x 90"(1) UNDERBUTTOCK DRAPE WITH POUCH(2) LEGGINS WITH 7" CUFF 30" x 42"(1) GOWN IMPERVIOUS REINFORCED LARGE SMS(3) TOWELS ABSORBENT 15" x 20"(1) PAD OBSTETRICAL X-LARGE(1) VAGINAL SPONGE XRD(10) GAUZE SPONGES 4" X 4" 12PLY XRD(1) CORD UMBILICAL CLAMP(1) BABY BLANKET PRINTED(2) EAR/ULCER SYRINGE 2oz(1) SET UP COVER CLEAR POLY(1) BASIN WASH 7QT.(1) ABDOMINAL DRAPE WITH TAPE LIF(2) KELLY FORCEP STRAIGHT 5 %(1) MAYO SCISSOR STRAIGHT 6%(1) BABY BEANNIESEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – SHOULDER PACK- CUSTOMED-(1) TABLE COVER REINFORCED 50" x 90" LIF(2) MAYO STAND COVER REINFORCED L/F(1) U-DRAPE 60" X 70" WITH TAPE SPLIT(4) TOWELS ABSORBENT 15" X 20" LIF(4) DRAPE UTILITY WITH TAPE LIF(2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE(1) SHEET DRAPE 70" X 100" SMS LIF(1) CUP SPECIMEN WITH CAP 4oz(1) TUBE SUCTION CONNECT. Y." X 12′ LIF(1) SKIN MARKER WITH RULER(1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF(1) BAG SUTURE FLORAL LIF(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF(1) NEEDLE HYPODERMIC 21G X 1% LIF(1) BLADE SURGICAL #11 CARBON STEEL(1) BLADE SURGICAL #15 CARBON STEEL(1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF(1) NEEDLE SPINAL ANESTH. 18G X 3% LIF(1) STOCKINETIE IMPERVIOUS 14" X 48" LIF(1) DRAPE BEACH CHAIR SHOULDER ARTHROSC.(1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP(2) GAUZE SPONGE 4" X 4" 16PL Y XRD L/FProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Laparoscopy pack; ; Code 900-3178; contains:(1) BULB SYRINGE 60cc LIF(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF(1) MAYO STAND COVER REINFORCED LIF(1) TABLE COVER REINFORCED 50" X 90" LIF(3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV(4) TOWEL ABSORBENT 15" X 20" LIF(1) DRAPE VIDEO CAMERA 13cm X 244cm LIF(3) LITE GLOVE LIF(1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78"(1) BLADE SURGICAL# 11(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF(4) DRAPE UTILITY WITH TAPE LIF(1) SUTURE BAG FLORAL L/F(1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR LIF(1) CABLE LAP 10FR 4MM MALE MONOP. LIF(1) SPECIMEN CONTAINER 4oz W/LID & LABEL(2) SHEET% 60" X 77" DRAPE REINFORCED LIF(1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF(1) WRAPPER 24" X 24" LIF(1) ULTRA VERES NEEDLE 120MM LIF(1) TROCAR ENDO.XCELL DILATING TIP 11 MM(1) TROCAR ENDO.XCELL DILATING TIP 5MM LIF(1) CANNULA 5MM XCEL SLEEVES LIF(2) DENTURE CUP 8oz W/LID(2) DRESSING NON ADH TELFA 4" X 3"(1) CHLORAPREP 26ML APPLICATOR TEAL LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF(2) BOWL UTILITY 16oz LIF(1) TIP CAUTERY POLISHER LIF(3) TOWELS ABSORBENT 15" X 20" LIF(1) BOWL UTILITY 32oz(1) BAG SUTURE FLORAL(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF(10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF(1) TABLE COVER REINFORCED 50" X 90" LIF(2) GOWN IMPERVIOUS REINFORCED LARGE SMS LIF(1) CAUTERY PENCIL ROCKER SWITCH LIF(1) BLADE SURGICAL #10 STAINLESS STEEL(1) TUBE SUCTION CO NNECTING ~" X 12′ LIF(5) LAP SPONGE PREWASH 18" X 18" XRD LIF(2) LITE GLOVES LIF(1) DRAPE LAPAROTOMY WITH POUCH 102" X 121" X 78" STD SMS(4) DRAPE UTILITY WITH TAPE LIF(1) CONTAINER SPECIMEN 4oz WITH LID & LABEL(1) BLADE SURGICAL #15 CARBON STEEL(2) SHEET DRAPE 41" X 69" MEDIUM LIF(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – Cirugia Cardiovascular Case Cart; c ode 900-1415A; contains:(1) CIRUGIA CARDIOVASCULAR .(INDUCCION)(1) CIRUGIA CARDIOVASCULAR (CIRUGIA )(1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERACIRCULANTE)(1) CIRUGIA CARDIOVASCULAR (PERFUSION SUPPLIES)(1) CIRUGIA CARDIOVASCULAR (POST- CIRUGIA)(1) OPEN HEART TRAYProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A; contains:(1) SOLUTION SURGICAL DURAPREP 26ml LIF(4) DRAPE UTILITY WITH TAPE LIF(3) TOWELS ABSORBENT 15" X 20" LIF(2) LEGGINS W/7" CUFF 30" X 42" LIF(1) BLADE SURGICAL# 15 STAINLESS STEEL(1) BLADE SURGICAL# 11 STAINLESS STEEL(1) GOWN IMPERV. EXTRA REINF. XLG AAMI Il l LIF(1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF(1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF(2) UTILITY BOWL 16oz. LIF(2) PK. STERI STRIP CLOSURE%" X 4" L/F(1) ACTIFOG WITH FOAM PAD SOLUTION LIF(1) TABLE COVER REINFORCED 50" X 90" LIF(1) MAYO STAND COVER REINFORCED LIF(1) NEEDLE ULTRA VERES 120MM LIF(1) STAPLE ARTICULATING ECHEL 60MM LIF(1) RELOAD WHITE 60MM ECHELON L/F(2) CANNULA 5MM XCEL SLEEVES LIF(1) TROCAR 5MM BLADELE W/STAB SLEEVE UF(1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF(1 0) LAP SPONGES PREWASH 18" X 18" XRD LIF(1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF(2) LITE GLOVE(1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF(1) ELECTRODE DUAL DEPRES(1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES(1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF(1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF(1) BAG SUTURE FLORAL(1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF(1) POLISHER CAUTERY TIP LIF(1) BAG GLASSINE(1) RELOAD BLUE 60MM LIF(1) TIME OUT BEACON NON WOVEN LIFProduct Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.Product Usage:EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PREMIUM O.B. PACK – CUSTOMED-(1) TABLE COVER REINFORCED 50" X 90" LIF(10) GAUZE SPONGES 4" X 4" 12PLY LIF(2) LEGGINS WITH 7" CUFF 30" x 42" LIF(2) PAD OBSTETRICAL X-LARGE ST.(2) SHEET DRAPE 42" X 55" LIF(1) UNDERBUTTOCK DRAPE WITH POUCH LIF(1) DRAPE ABDOMINAL 40" X 54" WITH TAPE LIF(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF(1) BOWL PLASTIC 80oz WITH LID(1) EAR ULCER SYRINGE 2oz LIF(1) CORD UMBILICAL CLAMP LIF(1) BABY BLANKET IMP. 30" X 30" POLY ABS. LIF(1) TOWELS ABSORBENT 15" X 20" LIF(1) LAP SPONGE PRE-WASH 18" X 18" XRD LIFEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – NEURO SPINE PACK – (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90"(4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS(4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP(1) DURAPREP SURGICAL SOLUTION 26mL UF (1) INCISION DRAPE 23" x 17"(1) INSTRUMENT POUCH (2) CAUTERY TIP POLISHER LIF(1) CAUTERY PENCIL HANDSWITCHING LIF (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL(1) YANKAUER SUCT. TUBE WITHOUT VENT LIF (2) LITE GLOVES LIF(1) TUBE SUCTION CONNECT. Y.." X 12′ LIF (1) SKIN MARKER WITH RULER(1) INCISE DRAPE ANTIMICROBIAL 23"x17" LIF (1) Pk SURGICAL STRIP W’X 6"(5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F (20) GAUZE SPONGE 4"X 4" 16 PLY XRD LIF(1) SCALPEL WITH HANDLE #10 STAINLESS STEEL (5) DRAPE % ECONOMY 53" X 77" LIF(2) TABLE COVER HD 77" X 110" L!F (1) MAYO TRAY LARGE(1) UTILITY BOWL 16 oz LIF (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F(2) SYRINGE 10cc WITHOUT NEEDLE LIL UF (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL(1) J VAC RESERVOIR 300 mLEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Aug-29-2014 Customed; Inc Customed – PEDIATRIC LAP PACK – ( I) SHEET MINOR LAP 102" X 121" X 78"( I) MAYO STAND COVER REINFORCED LIF( I) TABLE COVER REINFORCED 50" X 90" LIF(2) DRAPE SHEET 41 " X 58" SMS(2) TOWELS ABSORBENT 15" x 20" LIF(I ) BAG SUTURE FLORAL LIF(4) DRAPE UTILITY WITH TAPE L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.Aug-29-2014 Customed; Inc Customed – MINOR LAPAROTOMY PACK – (1) TABLE COVER 50" X 90" REINFORCED LIF(1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF(3) TOWELS ABSORBENT 15" X 20" LIF(1) YANKAUER SUCTION TUBE WITHOUT VENT LIF(2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR LIF(5) LAP SPONGE PREWASH XRD L/F(4) DRAPE UTILITY WITH TAPE LIF(2) LITES GLOVE LIF(1) TUBE SUCTION CONNECT. ~" X 12′ LIF(1) COVER MAYO STAND REINFORCED LIF(1) UTILITY BOWL 32oz(2) UTILITY BOWL 16oz(1) SPECIMEN CONTAINER 4oz WITH LID & LABEL(1) CAUTERY TIP POLISHER LIF(1) BLADE SURGICAL #10 CARBON STEEL(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF(1) BAG SUTURE FLORAL(1) DRAPE SHEET MEDIUM 41" X 69" LIF(1) DRAPE LAP WITH POUCH SMS STD L/FEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Date Posted, Recalling Manufacturer, Trade Name/Product, Reason for Recall

Aug-01-2014 Carestream Health Inc. KODAK DirectView DR 9000 System – KODAK DirectView DR 9000 System; Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) — A permanently installed diagnostic x-ray system composed of 3 main components: an operator console; U-Arm assembly with x-ray tube including a collimator; and a stationary generator. Carestream has identified a control system failure involving the Kodak Directview DR 9000 System that may cause the DR 9000 U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. This downward movement occurs at three times the normal rate of speed and will continue until the device control button is released; the

Aug-01-2014 Ortho-Clinical Diagnostics VITROS 4600 Chemistry System – VITROS 4600 Chemistry System (VITROS 5;1 FS System family member) — The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest; using both VITROS Chemistry Products Slides (colorimetric endpoint; rate; ion-selective electrode; and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) The VITROS Software is a part of the VITROS 3600; 4600; & 5600 Systems. The VITROS 3600; 4600; & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID); test requests; and patient demographics. Patient demographics include patient name; address; date of birth; gender; physician; and patient identification (PID). Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions; incorrect patient demographics were associated with a sample identification (ID) number.

Aug-01-2014 Ortho-Clinical Diagnostics VITROS 3600 Immunodiagnostic System – VITROS 3600 Immunodiagnostic System — For use in the in vitro quantitative; semi-quantitative and qualitative measurement of a variety of analytes of clinical interest; using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600; 4600; & 5600 Systems. The VITROS 3600; 4600; & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID); test requests; and patient demographics. Patient demographics include patient name; address; date of birth; gender; physician; and patient identification (PID). Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions; incorrect patient demographics were associated with a sample identification (ID) number.

Aug-01-2014 Ortho-Clinical Diagnostics VITROS 5600 Integrated System – VITROS 5600 Integrated System — For use in the in vitro quantitative; semi-quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Chemistry Products Slides; VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600; 4600; & 5600 Systems. The VITROS 3600; 4600; & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID); test requests; and patient demographics. Patient demographics include patient name; address; date of birth; gender; physician; and patient identification (PID). Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions; incorrect patient demographics were associated with a sample identification (ID) number.

Aug-01-2014 Advandx Inc AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures) – AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures); 50 tests. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC testCatalog number: QFFixBC1-50 (a component for QFSTABC1-50) Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test; failing QC

Aug-01-2014 X Spine Systems Inc Serrated Soft Tissue Shields – Serrated Soft Tissue Shields are surgical instruments and packaged as part of the Silex Sacroiliac Fusion System.The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System which is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. Revision B of the tissue shields of the device was 7 mm longer than the previous design.

Aug-02-2014 Zimmer; Inc. Tapered-Screw Vent Implant – Tapered-Screw Vent Implant; HA; 4.7mmD x 8mmL x 4.5mm; Part No. TSVWH8 Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."

Aug-04-2014 Brainlab AG Brainlab ExacTrac – ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures; in order to treat lesions; tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment. There is an anomaly internally detected by Brainlab in ExacTrac v.6.0.4; when using multiple isocenters (radiation treatment targets) within a single plan under unusual workflow circumstances. When using multiple isocenters (multiple radiation treatment targets) within a single plan; for a specific unusual workflow involving switching back to isocenters; for which X-ray or Cone Beam CT positioning

Aug-05-2014 Boston Scientific CRM Corp ENDOTAK RELIANCE SG – Boston Scientific ENDOTAK RELIANCE SG; transvenous defibrillation lead; Models 0180 & 0292; Sterile EO.Product Usage:The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems. A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically; some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.

Aug-06-2014 PerkinElmer Health Sciences; Inc. Panthera-Puncher 9 . – Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample; a dried blood disk; is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel; e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS. Risk of incorrect results from samples prepared with Panthera-Puncher 9

Aug-06-2014 Coltene Whaledent Inc Ultimate Dams – Latex Dental Dams labeled as Non-Latex Dental Dams Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation; the firm found that Latex dental dams had been packaged in Non-Latex packaging.

Aug-06-2014 BioMerieux SA VIDAS Total Prostate Specific Antigen – VIDAS TPSA intended for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma. Product is not approved or authorized for distribution in the US.

Aug-07-2014 PerkinElmer Health Sciences; Inc. PerkinElmer Specimen Gate Screening Center software – PerkinElmer Specimen Gate Screening Center software; version 1.4 and 1.6; Product Code: 5002-0500Specimen Gate Screening Center is intended for use as a data processing module in the storage; retrieving; and processing of laboratory data. Potential for demographic information and test result to be mismatch.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir – Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device; CSP and Blue Stripe Tubing; Item No. 011-46108-38Transpac Trifurcated monitoring kit with Safeset Reservoir; squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure; fluid infusion; and blood withdrawal. ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir – Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices; Needleless Valve and Macrodrip; Item No. 011-46104-33Transpac Trifurcated monitoring kit with Safeset Reservoir; squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure; fluid infusion; and blood withdrawal. ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Aug-07-2014 Stryker Instruments Div. of Stryker Corporation Sonopet Ultrasonic Aspirator Console – Sonopet Ultrasonic Surgical System Console; Ultrasonic Aspirator; Stryker Medtech. The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir – Single Transpac IT Monitoring Kit w/03 ml Flush Device; Needleless Valve; Macrodrip; Item No. 011-46106-29Transpac Trifurcated monitoring kit with Safeset Reservoir; squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure; fluid infusion; and blood withdrawal. ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir – Transpac IT w/10 cc Safeset Reservoir; 03 ml Flush Device; 2 CSP and Red Stripe Tubing; Item No. 011-46112-21Transpac Trifurcated monitoring kit with Safeset Reservoir; squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure; fluid infusion; and blood withdrawal. ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir – Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir; 03 ml Squeeze Flush and 6 Needleless Valves; Item No. 011-46106-22Transpac Trifurcated monitoring kit with Safeset Reservoir; squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure; fluid infusion; and blood withdrawal. ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir – Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP; With Velcro Arm Strap; Patient Mount; Item No. 011-46104-42Transpac Trifurcated monitoring kit with Safeset Reservoir; squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure; fluid infusion; and blood withdrawal. ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir – Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir; 03 ml Squeeze Flush and 2 Clave Sampling Ports; Item No. 46112-52Transpac Trifurcated monitoring kit with Safeset Reservoir; squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure; fluid infusion; and blood withdrawal. ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir – Arterial Transpac IT Monitoring Kit w/Safeset Reservoir; 03 ml Flush Device and 2 CSP; Item No. 011-46106-72Transpac Trifurcated monitoring kit with Safeset Reservoir; squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure; fluid infusion; and blood withdrawal. ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Aug-07-2014 ICU Medical; Inc. Transpac Trifurcated monitoring kit with Safeset Reservoir – Transpac IT w/3 ML/HR Macrodrip; Arterial Pressure Tubing and CSP; Item No. 011-46106-96Transpac Trifurcated monitoring kit with Safeset Reservoir; squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure; fluid infusion; and blood withdrawal. ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Aug-08-2014 Medtronic MiniMed Inc. Medtronic MiniMed Implantable Insulin Pump – Medtronic MiniMed Implantable Insulin Pump; Model No. MMT-2007D Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to the end of the 7 year useful life of the device.

Aug-08-2014 Biosound Esaote; Inc. Esaote PA230E Transducer – Esaote PA230E TransducerA portable and cart base ultrasound system for general and cardiovascular imaging Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth; could cause the transducer surface temperature to exceed the maximum allowable limit.

Aug-08-2014 Medtronic Neuromodulation Ascenda Intrathecal Catheter – Medtronic Ascenda Intrathecal Catheter models 8780 and 8781; and Ascenda Intrathecal Catheter Pump Segment Revision Kit; model 8784. The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and an Ascenda Intrathecal Catheter. Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits; which are used with the implantable SynchroMed drug infusion pump. This recall is being conducted due to a single component of the catheter; the retainer ring; not meeting specification criteria. There is a possibility of unintentional disconnection of the catheter from the pump; or difficulty in disconne

Aug-08-2014 Intuitive Surgical; Inc. EndoWrist Stapler System User Manual Addendum and Wall Chart – EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection; transection and/or creation of anastomoses in General; Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic). Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic

Aug-08-2014 Abbott Molecular Abbott Molecular – 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments. Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001; 57026001; 57059001; and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.

Aug-08-2014 Nanosphere; Inc. Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) – Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN); performed using the sample-to-result Verigene System; is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however; is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST); for identification of organisms not detected by BC-GN; to detect mixed infections that may not be detected by BC-GN; for association of antimicrobial resistance marker genes to a specific organisms; or for epidemiological typing. The BC-GN test is performed on the Verigene System platform; which is a fully automated; bench-top; molecular diagnostics workstation consisting of Verigene Reader and a bank of up to 32 Verigene Processor SP units. The System enables the detection of bacterial DNA from blood culture; unformed stool; or nasopharyngal swab; depending on the test; through automated nucleic acid extraction and hybridization. Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN Test Kit (20-005-021); which is labeled as "IVD". Therefore; Nanosphere has initiated a voluntary recall to retrieve the following BC-GN Test Cartridges: Test Ca

Aug-10-2014 Siemens Medical Solutions USA; Inc Siemens syngo RT Therapist and syngo RT Oncologist – Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data.

Aug-10-2014 Medtronic MiniMed Inc. Medtronic MiniMed Guardian Monitor – Medtronic MiniMed Guardian Monitor; Model No. CSS7100; CSS7100KProduct Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstick glucose measurement may be appropriate. Per the product labeling; all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters and not on the sensor glucose values provided by the Guardian REAL-Time monitor. The CSS7100 and CSS7100K monitors are identical expect for the fact that the CSS7100K monitor is a pediatric version that has a minimum programmable low alert setting of 90 mg/dL. The minimum programmable low glucose alert setting for the adult model (CSS7100) is 40 mg/dL. Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors.

Aug-10-2014 Carestream Health; Inc. Kodak DirectView DR 7500 Diagnostic X-Ray System – Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console; over head tube crane; x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the Beta Assembly detached from the OTC telescope; the lock nut was not

Aug-10-2014 Siemens Medical Solutions USA; Inc Siemens Digital Linear Acceletators – Siemens Linear Accelerators of type ARTISTE; ONCOR; and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option. The issue affects certain serial numbers of digital linear accelerators (LINAC) of type ARTISTE; ONCOR; and PRIMUS with automatic sequenced treatment delivery option. The safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a co

Aug-10-2014 Beevers Manufacturing & Supply; Inc. Luma Wrap – Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit. Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.

Aug-10-2014 AGFA Healthcare Corp. DX-D 600 – DX-D 600 – DXD Imaging PackageProduct Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull; spinal column and extremities; check abdomen and other both parts. Some customers reported that while using the DX-D600 in room or exam preparation; the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.

Aug-11-2014 ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products CA 19-9 Reagent Pack and CA 19-9 Calibrators – VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs; Lot 1320VITROS CA 19-9 Reagent Packs are used on VITROS ECi/ECiQ Immunodiagnostic Systems; VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma. Customers may receive positively biased results when using VITROS Immunodiagnostic Products CA 19-9 Total Reagent Packs; Lot 1320 and VITROS CA 19-9 Calibrators; Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems; the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators; Lot 1320 calibrator values.

Aug-11-2014 Integra LifeSciences Corp. Integra NewPort MIS System – Integra NewPort MIS SystemModel No.NWPIMP (NewPort Implant Tray w/ Components)NWP2INSTP (NewPort Instrument Tray w/ Components)The NewPort System is intended to be used as a temporary or permanent posterior; non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery.

Aug-12-2014 Codman & Shurtleff; Inc. Codman Cetras – Codman Certas – In Line Valve Only; Product Code: 82-8800The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Aug-12-2014 Codman & Shurtleff; Inc. "Codman Cetras – Codman Certas – In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus." To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Aug-12-2014 Codman & Shurtleff; Inc. "Codman Cetras – Codman Certas – In line Valve with Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus." To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Aug-12-2014 Codman & Shurtleff; Inc. "Codman Cetras – Codman Certas – In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus." To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Aug-12-2014 Codman & Shurtleff; Inc. Codman Cetras – Codman Certas – In Line Valve with SIPHONGUARD Device; Catheter and Accessories; Product Code: 82-8805The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Aug-12-2014 Codman & Shurtleff; Inc. Codman Cetras – Codman Certas – In Line Valve with SIPHONGUARD Device; Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8807The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Aug-12-2014 Codman & Shurtleff; Inc. Codman Cetras – Codman Certas – In Line Valve with Catheter and Accessories; Product Code: 82-8801The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Aug-12-2014 Codman & Shurtleff; Inc. Codman Cetras – Codman Certas – In Line Valve with SIPHONGUARD; Unitized Catheter and Accessories; Product Code: 82-8806The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Aug-13-2014 Brainlab AG Brainlab – Navigation Spine & Trauma 3D Version 2.0 and 2.1Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe; tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data.The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure; such as the skull; the pelvis; a long bone or vertebra can be identified relative to the acquired image (CT; MR; 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration; the software requires the gantry position of the scanner. The gantry position can either be entered manually or submitted automatically from the CT scanner. If automatic gantry communication is available; the so-called "table-ze

Aug-13-2014 Zimmer; Inc. Moore Hip Prosthesis Long Fenestrated Stem – Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length.Product Usage:The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement. Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically; 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached either the inner or outer package tray. Zimmer has not received any complaints of damaged package trays for these 20 lot

Aug-13-2014 Biomet; Inc. Distal Radius Fracture Repair System – Device Brand Name: Distal Radius Fracture Repair SystemDevice Classification Name: Plate; Fixation; BoneDevice Common Name: Drill Guide DNP 3.3mmLabeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581 The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prismaflex TPE 2000 set; Product Number 1071441. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US); Product Number 800541 Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US); 1 MARS Treatment Kit per carton box; Product Number 800480; Batch Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Gambro Renal Products; Incorporated Gambro – Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch; 4 pouches per carton box Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Aug-13-2014 Medical Positioning Inc Medical Positioning Rapid Response HUT table – Medical Positioning Rapid Response HUT table; Powered Medical Examination table; Model # 1219. Product Usage: Used to conduct syncope examinations. Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.

Aug-13-2014 Medical Positioning Inc Medical Positioning Rapid Response HUT table – Medical Positioning Rapid Response HUT table; Powered Medical Examination table; Model # 1019. Product Usage: Used to conduct syncope examinations. Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.

Aug-13-2014 Medical Positioning Inc Medical Positioning Rapid Response HUT table – Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section; Powered Medical Examination table; Model # 1217.Product Usage: Used to conduct syncope examinations. Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.

Aug-13-2014 Ortho-Clinical Diagnostics VITROS Calibration Data Module – VITROS Calibration Data Module (CDM PROM); Catalog Number 1999077; used in conjunction with VITROS Chemistry Products NH3 DT Slides; GEN 59 (REF/Product Code 1532589) and VITROS Chemistry Products DT Calibrator Kit 44 (REF/Product Code 1957927)For in vitro diagnostic use only. The Calibration Data Module (CDM) is an electronic device that contains assay specific data that is required to calibrate and use assays on the VITROS Chemistry Products DT60/ DT60 II System. Inability to calibrate or use VITROS NH3 DT Slides; GEN 59 with VITROS Chemistry Products DT Calibrator Kit; Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.

Aug-13-2014 Medical Positioning Inc Medical Positioning Rapid Response HUT table – Medical Positioning Rapid Response HUT table; Powered Medical Examination table; Model # 1017. Product Usage: Used to conduct syncope examinations. Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.

Aug-13-2014 Nidek Inc GYC-1000 Green Laser Photocoagulator system – GYC-1000 Green Laser Photocoagulator systemThe Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures; including retinal and macular photocoagulation; iridotomy and trabeculoplasty. Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation;

Aug-14-2014 Nellcor Puritan Bennett Inc. (dba Covidien LP) Covidien – Vital Sync RMS 1.0 when loaded with v2.4 software; packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box.The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data; waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner. Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.

Aug-14-2014 Nellcor Puritan Bennett Inc. (dba Covidien LP) Covidien – Vital Sync" VPMP & IM; software; V2.4. (DVD); packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box.The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data; waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner. Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.

Aug-14-2014 Philips Medical Systems (Cleveland) Inc IntelliSpace Portal DX/HX/EX; IntelliSpace Portal IX; and IntelliSpace Portal LX SPECT – IntelliSpace Portal (ISP) DX/HX/EX; IntelliSpace Portal (ISP) IX; and IntelliSpace Portal (ISP) LX SPECTIntelliSpace Portal (ISP) is a multimodality (CT; NM; and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking; selection; processing and filming of multimodality DICOM images. The following software issues have been identified in the affected products.Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application; the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances; the ejection fraction (

Aug-14-2014 BioMerieux SA VIDAS D-Dimer Exclusion II – VIDAS D-Dimer Exclusion II; an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease. Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the medical decision point of 500 ng/mL that initially tested at <45 ng/mL.

Aug-14-2014 Zimmer; Inc. Double Offset Rasp Handle; Left Hand – Double Offset Rasp Handle; Left HandNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Version 2 D8L OFFSET RASP HANDLE; RT – VER2 D8L OFFSET RASP HANDLE; RTNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. 23.5 Degree Anterior Supine Double Offset Rasp Handle – 23.5 Deg Rasp Handle Assy- LEFTNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Double Offset Rasp Handle; Right Hand – Double Offset Rasp Handle; Right HandNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Version 2 DBL OFFSET RASP HANDLE; LT – VER2 DBL OFFSET RASP HANDLE; LTNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Double Offset Rasp Handles – Version 1 with larger strike plate – Vl DBL OFFST WI LRG STPL; RTNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. 23.5 Degree Anterior Supine Double Offset Rasp Handle – 23.5 Deg Rasp Handle Assy- RIGHTNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Greatbatch Double Offset Rasp Handle; Left Hand – Double Offset Rasp Handle; Left HandA/S Rasp Handle (Left) The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Double Offset Rasp Handle; Right Hand – Double Offset Rasp Handle; Right HandNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Double Offset Rasp Handles – Version 1 with larger strike plate – VI DBL OFFST W/ LRG STPL; LTNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Double Offset Rasp Handles – Version 2 – PIN REWORK – VER2 HANDLE; PIN REWORK; RTNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Double Offset Rasp Handle; Left Hand – Double Offset Rasp Handle; Left HandNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Double Offset Rasp Handle; Left Hand – Double Offset Rasp Handle; Left HandNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Greatbatch Double Offset Rasp Handle; Right Hand – Double Offset Rasp Handle; Right HandA/S Rasp Handle (Right) The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Double Offset Rasp Handle; Left Hand – Double Offset Rasp Handle; Left HandNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Zimmer; Inc. Double Offset Rasp Handles – Version 2 – PIN REWORK – VER2 HANDLE; PIN REWORK; LTNonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes; including fracture of the leaf spring.

Aug-14-2014 Nanosphere; Inc. Nanosphere Verigene – Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions; including wash solutions; oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however; is not used to monitor these infections. Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.

Aug-15-2014 Omnilife Science Inc. Apex Arc Hip Stem; Size 2; HA Coated – Apex Arc Hip Stem; Size 2; HA Coated; Product Code: HC-21002-HA Staining on hip implant.

Aug-15-2014 TomoTherapy Incorporated TomoTherapy Treatment System – TomoTherapy Treatment System; Model: Hi-Art; Catalog/Part Number: H-0000-0003; software versions 1.2.0; 1.2.1 and 1.2.2 (Hi-Art 4.2.0; 4.2.1 and 4.2.2). . Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0; 1.2.1 and 1.2.2 (Hi-Art 4.2.0; 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these software versions.

Aug-15-2014 Biomet; Inc. Vanguard 360 Revision Knee System – Vanguard 360 Femoral Boss Reamer; Label: REF 32-488474VANGUARD 360 1NSTRUMENTFEMORAL BOSS REAMERNON-STERILE; BIOMET ORTHOPEDICS56 EAST BELL DRIVEP.O. BOX 587 WARSAW; IN 46581 USA The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.

Aug-15-2014 TomoTherapy Incorporated TomoTherapy Treatment System – TomoTherapy Treatment System; Model: Hi-Art; Catalog/Part Number: H-0000-0003; software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy; stereotactic radiotherapy; or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational; non-rotational; modulated (IMRT); or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physicians prescribed and approved plan. Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.

Aug-15-2014 Siemens Healthcare Diagnostics; Inc. Dimension Clinical Chemistry System Wash – Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement. Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I; CTNI (RF421C); LTNI (RF521C); Free T4; FT4 (RF410); Thyroid Stimulating Hormone; TSH (RF412); and N-terminal pro-brain natriuretic peptide; PBNP (RF423A) and LPBN (RF523A) when using Dimension&reg; Chemistry Wash lot RD41041.Internal inv

Aug-16-2014 Philips Healthcare Informatics; Inc. Philips IntelliSpace PACS 4.4 Image Management Systems – Philips IntelliSpace PACS 4.4 image management systems performs digital image processing; measurement and communication and storage. A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS; the unchanged data may export causing the potential for diagnosis on incomplete data.

Aug-16-2014 Zimmer; Inc. – 6.5 mm Cancellous Screw Fully Threaded Sterilezimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Aug-16-2014 Zimmer; Inc. – 6.5 mm Cancellous Screw 16 mm Thread LengthSterilezimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Aug-16-2014 Zimmer; Inc. – 4.0 mm Cancellous Screw; Partially ThreadedSterileZimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Aug-16-2014 Zimmer; Inc. Magna-Fx Cannulated Screw Fixation System – Magna-Fx Cannulated Screw Fixation SystemBone Screw Fully ThreadedSterilezimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Aug-16-2014 Zimmer; Inc. – 6.5 mm Cancellous Screw 32 mm Thread LengthSterilezimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Aug-16-2014 Zimmer; Inc. Magna-Fx Cannulated Screw Fixation System – Magna-Fx Cannulated Screw Fixation SystemCannulated Bone ScrewSterilezimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Aug-16-2014 Zimmer; Inc. – 6.5 mm Cancellous Screw Fully ThreadedSterilezimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Aug-16-2014 Zimmer; Inc. – 4.5 mm Malleolar ScrewSterilezimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Aug-17-2014 Ortho Development Corporation Tibila Insert CK – Tibila Insert CK; Balanced Knee System Revision; REF563-1YYYProduct Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed Ortho Development is recalling various Pivot Bipolar Cup; Patella; PS Tibial Insert; UC Tibila Insert; and CK Tibil Insert because the foil pouches did not properly seal; allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.

Aug-17-2014 Ortho Development Corporation Pivot Bipolar Cup – Pivot Bipolar Cup 22×42/43-51/53mm; REF 133-YYYYProduct Usage:Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum Ortho Development is recalling various Pivot Bipolar Cup; Patella; PS Tibial Insert; UC Tibila Insert; and CK Tibil Insert because the foil pouches did not properly seal; allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.

Aug-17-2014 Smith & Nephew; Inc. TRIGEN(R) INTERTAN(TM) NAIL – TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL; 125o; REF 71675201; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL; 125o; REF 71675202; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 13MM X 18 CM NAIL; 125o; REF 71675203; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 20 CM NAIL; 125o; REF 71675204; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 11.5MM X 20 CM NAIL; 125o; REF 71675205; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 13MM X 20 CM NAIL; 125o; REF 71675206; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL; 130o; REF 71675207; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL; 130o; REF 71675208; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 13MM X 18 CM NAIL; 130o; REF 71675209; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 20 CM NAIL; 130o; REF 71675210; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 11.5MM X 20 CM NAIL; 130o; REF 71675211; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 13MM X 20 CM NAIL; 130o; REF 71675212; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 26 CM NAIL; 125o; LEFT; REF 71675213; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 32 CM NAIL; 125o; LEFT; REF 71675219; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 34 CM NAIL; 125o; LEFT; REF 71675221; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 34 CM NAIL; 125o; RIGHT; REF 71675222; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 36 CM NAIL; LEFT; 125o; REF 71675223; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 38 CM NAIL; 125o; LEFT; REF 71675225; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 40 CM NAIL; 125o; LEFT; REF 71675227; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 40 CM NAIL; 125o; RIGHT; REF 71675228; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 28 CM NAIL; 125o; RIGHT; REF 71675238; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 32 CM NAIL; 125o; LEFT; REF 71675241; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 34 CM NAIL; 125o; LEFT; REF 71675243; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 34 CM NAIL; 125o; RIGHT; REF 71675244; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 11.5MM X 36 CM NAIL; 125o; LEFT; REF 71675245; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 11.5MM X 36 CM NAIL; 125o; RIGHT; REF 71675246; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 38 CM NAIL; 125o; LEFT; REF 71675247; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 38 CM NAIL; 125o; RIGHT; REF 71675248; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 40 CM NAIL; 125o; LEFT; REF 71675249; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 11.5MM X 40 CM NAIL; 125o; RIGHT; REF 71675250; QTY (1); STERILE R; Smith & Nephew; Memphis; Inc.; TN 38116TRIGEN(R) INTERTAN(TM) 10MM X 26 CM NAIL; 130o; LEFT; REF 71675257; QTY (1); STERILE R; Smi There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.

Aug-17-2014 Ortho Development Corporation Tibila Insert UC – Tibila Insert UC; Balanced Knee System; REF163-3YYYProduct Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component Ortho Development is recalling various Pivot Bipolar Cup; Patella; PS Tibial Insert; UC Tibila Insert; and CK Tibil Insert because the foil pouches did not properly seal; allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.

Aug-17-2014 Ortho Development Corporation Patella – Patella 38mm; REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component Ortho Development is recalling various Pivot Bipolar Cup; Patella; PS Tibial Insert; UC Tibila Insert; and CK Tibil Insert because the foil pouches did not properly seal; allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.

Aug-17-2014 Ortho Development Corporation PS Tibial Insert – PS Tibial Insert; REF 163-1XXXProduct Usage:UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component Ortho Development is recalling various Pivot Bipolar Cup; Patella; PS Tibial Insert; UC Tibila Insert; and CK Tibil Insert because the foil pouches did not properly seal; allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.

Aug-18-2014 Angiodynamics; Inc. Uni*Fuse Infusion System with Cooper Wire – Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE; 5F x 90 cm x 10 cm Infusion Pattern; Catalog No./REF 12401806; Product No. H787124018065; STERILE — AngioDynamics; 603 Queensbury Avenue; Queensbury; NY 12804 AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).

Aug-18-2014 Angiodynamics; Inc. Uni*Fuse Infusion System with Cooper Wire – Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE; 5F x 90 cm x 30 cm Infusion Pattern; Catalog No./REF 12401808; Product No. H787124018085; STERILE — AngioDynamics; 603 Queensbury Avenue; Queensbury; NY 12804 AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).

Aug-18-2014 Angiodynamics; Inc. Uni*Fuse Infusion System with Cooper Wire – Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE; 5F x 90 cm x 40 cm Infusion Pattern; Catalog No./REF 12401809; Product No. H787124018095; STERILE — AngioDynamics; 603 Queensbury Avenue; Queensbury; NY 12804 AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).

Aug-18-2014 Vascutek; Ltd. Gelweave (TM) Vascular Prostheses – Gelweave (TM) Vascular ProsthesesManufactured by – VASCUTEK Ltda TERUMO company The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label; versus that of the graft (4 years and 5 years; respectively).

Aug-18-2014 Medtronic Neuromodulation Activa PC – Medtronic; Activa PC; Model 37601; Method of Sterilization: Ethylene Oxide; Single Use Only; Rx Only. The Activa PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle; connected to an extension and leads; which are implanted in the brain. Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.

Aug-18-2014 Biolase Technology Inc WaterLase iPius – WaterLase iPlus Dental Laser System; Part No. 7200854-XXSoftware Upgrade Kit; Part No. 6201463. Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure screen; the air setting will change to 1% and OFF.

Aug-18-2014 Hyperion Medical HyperBlue 1530; multi-use diode laser – All brochures printed before November 20; 2013 for the HyperBlue 1530; including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3; 2013. Brochures and web site information for the Hyper blue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. Specifically; the web site and brochures misbranded the product with claims that it could use 940 nm; 808 nm; and 532 nm wavelengths as single wavelengths or in combination with other wavelengths; as well as a claim that the produc

Aug-19-2014 Synthes; Inc. Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set – Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set A screw set was returned from the field for destruction after being exposed to flood water; which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.

Aug-19-2014 Gyrus Medical; Inc Falope-Ring Dilator – Gyrus ACMI Falope-Ring Dilator; item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide; an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands. Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator.

Aug-19-2014 Intelerad Medical Systems IntelePACS – IntelePACS software versions 3-8-1 to 4-9-1; Product Usage:IntelePACS is a device that receives digital images and data from various sources (such as; CT scanners; MRI scanners; ultrasound systems; R/F units; computer and direct radiographic devices; secondary capture devices; scanners; imaging gateways; or other imaging sources. In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated.

Aug-19-2014 Ansar Group; Inc. Dba Ansar Medical Technologies; Inc ANSAR ANX-3.0 Autonomic Monitor system – blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of a number of FDA 510 K market clearance components. The components are the following: 1. Patient Physiological Monitor; 2. Laptop Computer; 3. Stand w/wheels; 4. Patient cables; 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro; 510 K number K001775; Zoe Medical Nightingale Monitoring system; 510 K number; Ivy Biomedical model 405P; K955546; Software components: Ansar ANS C 3000; K941252The device is also referred to as the ANS-C3000 Ansar Group; Inc. recalled the blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system because of complaints that it occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate; resulting in no BP measured.

Aug-19-2014 Invivo Corporation Philips Expression IP5 Information Portal – Philips IP5 Information PortalThe Expression Information Portal (Model IP5); a display and device controller for Philips MRI patient monitoring systems; is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures. The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.

Aug-20-2014 GE Healthcare; LLC Discovery XR656 – GE Healthcare; Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull; spinal column; chest; abdomen; extremities and other body parts in patients of all ages. GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall stand systems.There have been reported incidents of detector falls; but no injuries have been reported.

Aug-20-2014 Zimmer; Inc. PERSONA (TM) – PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray; non-sterileThe intended use of the sterilization case is to organize; store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel. The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide.

Aug-20-2014 Zimmer; Inc. PERSONA (TM) – PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray; non-sterileThe intended use of the sterilization case is to organize; store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel. The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide.

Aug-20-2014 ICU Medical; Inc. MicroClave – Cap Change Kit with MicroClave Clear Connector; Item No. B79103BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch. ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Aug-20-2014 ICU Medical; Inc. MicroClave – CAP Change Kit w/MicroClave Clear; Item No. B78109BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch. ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Aug-20-2014 ICU Medical; Inc. MicroClave – Port Access Kit with MicroClave Clear Connector; Item No. B79104BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch. ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Aug-21-2014 Pentax Medical Company Pentax Medical Inc. – PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.

Aug-21-2014 Zimmer; Inc. Persona TASP PS – Persona (TM) The Personalized Knee SystemPS Tibial Articular Surface Provisional TopNonsterileTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 3-5 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 6-9 CD TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 3-5 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 6-9 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 10-11 EF TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 6-9 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 GH TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOPTASP PS L 10-12 J TOP Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

Aug-21-2014 Zimmer; Inc. Persona TASP – Persona (TM) The Personalized Knee SystemCPS Tibial Articular Surface Provisional TopNonsterileTASP MLC L 3-5 CD TOPTASP MLC L 6-9 CD TOPTASP MLC L 3-5 EF TOPTASP MLC L 6-9 EF TOPTASP MLC L 10-11 EF TOPTASP MLC L 6-9 GH TOP Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

Aug-21-2014 Zimmer; Inc. Persona TASP – Persona (TM) The Personalized Knee SystemUC Tibial Articular Surface Provisional TopNonsterileTASP UC L 3-7 CD TOPTASP UC L 4-11 EF TOPTASP UC L 7-12 GH TOPTASP UC L 9-12 J TOP Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

Aug-21-2014 Zimmer; Inc. Persona TASP – Persona (TM) The Personalized Knee SystemTibial Articular Surface Provisional BottomNonsterileTASP L CD BOTTOM; +0MMTASP L CD BOTTOM; +6MMTASP L EF BOTTOM; +0MMTASP L EF BOTTOM; +6MMTASP L GH BOTTOM; +0MMTASP L GH BOTTOM; +6MMTASP L J BOTTOM; +0MMTASP L J BOTTOM; +6MMTASP R CD BOTTOM; +0MMTASP R CD BOTTOM; +6MMTASP R EF BOTTOM; +0MMTASP R EF BOTTOM; +6MMTASP R GH BOTTOM; +0MMTASP R GH BOTTOM; +6MMTASP R J BOTTOM; +0MMTASP R J BOTTOM; +6MM Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

Aug-21-2014 Zimmer; Inc. Persona TASP – Persona (TM) The Personalized Knee SystemCR Tibial Articular Surface Provisional TopNonsterileTASP CR L 3-9 CD TOP Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

Aug-21-2014 Zimmer; Inc. Persona TASP – Persona (TM) The Personalized Knee SystemTibial Articular Surface Provisional BottomNonsterilePSN A/S PROV L CD BOTTOM +0MMPSN A/S PROV L CD BOTTOM +6MMPSN A/S PROV L EF BOTTOM +0MMPSN A/S PROV L EF BOTTOM +6MMPSN A/S PROV L GH BOTTOM +0MMPSN A/S PROV L GH BOTTOM +6MMPSN A/S PROV L J BOTTOM +0MMPSN A/S PROV L J BOTTOM +6MMPSN A/S PROV R CD BOTTOM +0MMPSN A/S PROV R CD BOTTOM +6MMPSN A/S PROV R EF BOTTOM +0MMPSN A/S PROV R EF BOTTOM +6MMPSN A/S PROV R GH BOTTOM +0MMPSN A/S PROV R GH BOTTOM +6MMPSN A/S PROV R J BOTTOM +0MMPSN A/S PROV R J BOTTOM +6MM Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

Aug-21-2014 Philips Medical Systems; Inc. Philips IntelliSpace ECG Management System – Philips IntelliSpace ECG Management System; with software option C61 needed to import ECGs from the Quinton Stress ECG System.Model No. 860426 Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name; patient ID (PID); Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy.

Aug-22-2014 Medtronic MiniMed Inc. Medtronic MiniMed Paradigm REAL-Time and Paradigm REAL-Time Revel CGM System and MiniMed 530G System – Medtronic MiniMed Paradigm Insulin Infusion Pumps; Paradigm models: MMT-511; MMT-512; MMT-712; MMT-712E; MMT-515; MMT-715; MMT-522; MMT-522K; MMT-722; MMT-722K; MMT-523; MMT-523K; MMT-723; MMT-723K; MMT-554; and MMT-754.MiniMed 530G: MMT-551; and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes. Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.

Aug-22-2014 Zimmer; Inc. Persona Distal Valgus Alignment Guide – PERSONA Distal Valgus Alignment Guide; Nonsterile Qty-1***Zimmer WARSAW; IN 46580; U.S.A.The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made. Persona Distal Valgus Alignment guide collet locks are seizing in the ‘unlocked’ position.

Aug-22-2014 Becton Dickinson & Company Becton Dickinson and Company – BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin; 8 mL; 16 x 125 mm; Catalog #REF 362753; Lot #4063409 with expiry 03/2015; intended for the collection of whole blood and the separation of mononuclear cells. BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation; resulting in a reduced number of recovered mononuclear cells.

Aug-26-2014 Zimmer; Inc. Zimmer Patellofemoral Joint (PFJ) Prosthesis – Gender Solution Patello-Femoral Joint System Patello-Femoral TrochleaComponent; Precoat; Size 4; LeftProduct Usage:The Zimmer Patellofemoral Joint (PFJ) Prosthesis is designed to closely replicate the anatomic features of the patellar groove on the femur. The implants articulating surface incorporates the NexGen knee systems frontal profile geometry for optimal patella tracking for both resurfaced and unresurfaced patellae. The construct of the PFJ prosthesis accommodates a wide range of patients; both female and male. Five sizes in left and right configurations are being offered for this implant. Intended use:  Osteoarthritis; traumatic arthritis; polyarthritis; and/or severe chondrocalcinosis of the patellofemoral joint;  The salvage of previously failed surgical attempts (e.g.; arthroscopy; lateral release; cartilage transplantation);  History of patellar dislocation or patella fracture;  Dysplasia-induced degeneration This device is intended for cemented use only. Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. A forged lap is a defect that forms when metal folds over itself during forging.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 11.0 and 11.5Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 18.5-19.0Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 23; 23.5 & 24.Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 29; 29.5 & 30.Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 16.5; 17.0Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 12.0 and 12.5Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 26.5; 27; 27.5 & 28.5.Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 15.5; 16.0Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 21.5-22.5Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 14.5; 15.0Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 24.5; 25; 25.5 & 26.Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 13.0; 13.5; 14.0Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 17.5; 18.0Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 10.0 and 10.5Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 19.5-20Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 20.5-21Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 AMO Puerto Rico Manufacturing; Inc. TECNIS CL – AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design; Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0; 5.5; 6.0; 6.5; 7.0; 7.5; 8.0; 8.5; 9.0; 9.5Product Usage:AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. AMO is voluntarily recalling lots of Silicone IOL with OptiEdge Design (Model Z9002) because units may be labeled with the incorrect diopter power.

Aug-26-2014 Zimmer; Inc. Moore & Thompson Hip Stems – Moore & Thompson Hip Stems:FNSTRD HIP 38HDX127STFNSTRD HIP 40HDX127STFNSTRD HIP 41HDX127STFNSTRD HIP 42HDX127STFNSTRD HIP 43HDX127STFNSTRD HIP 44HDX127STFNSTRD HIP 45HDX140STFNSTRD HIP 46HDX140STFNSTRD HIP 47HDX140STFNSTRD HIP 48HDX140STFNSTRD HIP 49HDX140STFNSTRD HIP 50HDX152STFNSTRD HIP 51HDX152STFNSTRD HIP 52HDX152STFNSTRD HIP 53HDX152STFNSTRD HIP 54HDX152STFNSTRD HIP 55HDX152STFNSTRD HIP 57HDX152STFNSTRD HIP 60HDX152STFNSTRD HIP 63HDX152STFNSTRD HIP 38HDX140STFNSTRD HIP 40HDX140STFNSTRD HIP 41HDX140STFNSTRD HIP 42HDX140STFNSTRD HIP 43HDX140STFNSTRD HIP 44HDX140STFNSTRD HIP 45HDX152STFNSTRD HIP 46HDX152STFNSTRD HIP 47HDX152STFNSTRD HIP 48HDX152STFNSTRD HIP 49HDX152STFNSTRD HIP 50HDX152STFNSTRD HIP 51HDX152STHIP PROS 38HDX105STHIP PROS 40HDX105STHIP PROS 41HDX105STHIP PROS 42HDX105STHIP PROS 43HDX105STHIP PROS 44HDX105STHIP PROS 45HDX105STHIP PROS 46HDX105STHIP PROS 47HDX105STHIP PROS 48HDX105STHIP PROS 49HDX105STHIP PROS 50HDX105STHIP PROS 51HDX105STHIP PROS 52HDX105STHIP PROS 53HDX105STHIP PROS 54HDX105STHIP PROS 55HDX105STHIP PROS 57HDX105STHIP PROS 60HDX105STHIP PROS 63HDX105STFNSTRD HIP 38HDX165STFNSTRD HIP 40DX165STFNSTRD HIP 41HDX165STFNSTRD HIP 42HDX165STFNSTRD HIP 43HDX165STFNSTRD HIP 44HDX165STFNSTRD HIP 45HDX165STFNSTRD HIP 46HDX165STFNSTRD HIP 47HDX165STFNSTRD HIP 48HDX165STFNSTRD HIP 49HDX165STFNSTRD HIP 50HDX191STFNSTRD HIP 51HDX191STFNSTRD HIP 52HDX191STFNSTRD HIP 53HDX191STFNSTRD HIP 54HDX191STFNSTRD HIP 55HDX191STFNSTRD HIP 57HDX191STFNSTRD HIP 60HDX191STFNSTRD HIP 63HDX191STFNSTRD HIP 38HDX165STFNSTRD HIP 41HDX165STFNSTRD HIP 43HDX165STFNSTRD HIP 44HDX165STFNSTRD HIP 46HDX165STFNSTRD HIP 48HDX165STFNSTRD HIP 49HDX165STFNSTRD HIP 51HDX165STHIP PROS 38HDX127STHIP PROS 40HDX127STHIP PROS 41HDX127STHIP PROS 42HDX127STHIP PROS 43HDX127STHIP PROS 44HDX127STHIP PROS 45HDX140STHIP PROS 46HDX140STHIP PROS 47HDX140STHIP PROS 48HDX140STHIP PROS 49HDX140STHIP PROS 50HDX152STHIP PROS 51HDX152STHIP PROS 52HDX152STHIP PROS 53HDX152STHIP PROS 54HDX152STHIP PROS 55HDX152STHIP PROS 57HDX152STHIP PROS 60HDX152STHIP PROS 63HDX152STHIP PROS 38HDX165STHIP PROS 40HDX165STHIP PROS 41HDX165STHIP PROS 42HDX165STHIP PROS 43HDX165STHIP PROS 44HDX165STHIP PROS 45HDX165STHIP PROS 46HDX165STHIP PROS 47HDX165STHIP PROS 48HDX165STHIP PROS 49HDX165STHIP PROS 50HDX191STHIP PROS 51HDX191STHIP PROS 52HDX191STHIP PROS 53HDX191STHIP PROS 54HDX191STHIP PROS 55HDX191STHIP PROS 57HDX191STHIP PROS 60HDX191STHIP PROS 63HDX191ST Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically; multiple test samples fromeach of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Aug-26-2014 Zimmer; Inc. Trauma Large Screws – Trauma Large Screws:CANN BONE SCREW 7.0MMX100MMLGCANN BONE SCREW 7.0X105LGCANN BONE SCREW 7.0X105LGCANN BONE SCREW 7.0MMX105MMLGCANN BONE SCREW 7.0X110LGCANN BONE SCREW 7.0X110LGCANN BONE SCREW 7.0MMX110MMLGCANN BONE SCREW 7.0X115LGCANN BONE SCREW 7.0X115LGCANN BONE SCREW 7.0MMX115MMLGCANN BONE SCREW 7.0X120LGCANN BONE SCREW 7.0X120LGCANN BONE SCREW 7.0MMX120MMLGCANN BONE SCREW 7.0X125LGCANN BONE SCREW 7.0MMX125MMLGCANN BONE SCREW 7.0X130LGCANN BONE SCREW 7.0MMX130MMLGRECON SCR LGE 5.5MMDX105MMRECON SCR LGE 5.5MMDX110MMRECON SCR LGE 5.5MMDX115MMRECON SCR LGE 5.5MMDX120MMRECON SCR LGE 5.5MMDX125MMRECON SCR LGE 5.5MMDX130MMITST ANTI-ROT SCR 6.5MMDX105MMITST ANTI-ROT SCR 6.5MMDX110MMPERI. SCR 3.5MM X105MMLPERI SCR. 6.5MM X 100MM LPERI SCR. 6.5MM X 140MM LPERI SCR. 6.5MM X 100MM LPERI SCR. 6.5MM X 100MM L3.5MM CORT SCR X 105MM SELFTAP3.5MM CORT SCR X 110MM SELFTAP5.5MM X 100MM CANN LKNG SCREWZ NAIL 6.0 X 105 CANC SCREW PTZ NAIL 6.0 X 110 CANC SCREW PTZ NAIL 6.0 X 115 CANC SCREW PTZ NAIL 6.0 X 120 CANC SCREW PTZ NAIL 6.0 X 125 CANC SCREW PTZ NAIL 6.0 X 130 CANC SCREW PTZ NAIL 6.0 X 135 CANC SCREW PTZ NAIL 6.0 X 140 CANC SCREW PTZ NAIL 6.0 X 105 CANC SCREW FAZ NAIL 6.0 X 110 CANC SCREW FAZ NAIL 6.0 X 115 CANC SCREW FAZ NAIL 6.0 X 120 CANC SCREW FAZ NAIL 6.0 X 125 CANC SCREW FAZ NAIL 6.0 X 130 CANC SCREW FAZ NAIL 6.0 X 135 CANC SCREW FAZ NAIL 6.0 X 140 CANC SCREW FAZ NAIL 6.0 X 105 CANC SCREW PTZ NAIL 6.0 X 110 CANC SCREW PTZ NAIL 6.0 X 115 CANC SCREW PTZ NAIL 6.0 X 120 CANC SCREW PTZ NAIL 6.0 X 125 CANC SCREW PTZ NAIL 6.0 X 130 CANC SCREW PTZ NAIL 6.0 X 135 CANC SCREW PTZ NAIL 6.0 X 140 CANC SCREW PTZ NAIL 6.0 X 105 CANC SCREW FAZ NAIL 6.0 X 110 CANC SCREW FAZ NAIL 6.0 X 115CANC SCREW FAZ NAIL 6.0 X 120CANC SCREW FAZ NAIL 6.0 X 125 CANC SCREW FAZ NAIL 6.0 X 130 CANC SCREW FAZ NAIL 6.0 X 135 CANC SCREW FAZ NAIL 6.0 X 140 CANC SCREW FA3.5X105 CORT SCR3.5 X 105 CORT SCR SELF TAP3.5X110 CORT SCR3.5 X 110 CORT SCR SELF TAP3.5X115 CORT SCR3.5 X 115 CORT SCR SELF TAP3.5X120 CORT SCR3.5 X 120 CORT SCR SELF TAP3.5X125 CORT SCR3.5X130 CORT SCR3.5X135 CORT SCR3.5X140 CORT SCR3.5X145 CORT SCR3.5X150 CORT SCR4.5 X 105 CORT SCR SELF TAP4.5 X 110 CORT SCR SELF TAP4.5 X 120 CORT SCR SELF TAP6.5X105 CANC SCR; FULLY THDED6.5X105 CANC SCR; 16MM THD6.5X105 CANC SCR; 32MM THD6.5X110 CANC SCR; FULLY THDED6.5X110 CANC SCR; 16MM THD6.5X110 CANC SCR; 32MM THD6.5X115 CANC SCR; 32MM THD6.5X120 CANC SCR; 32MM THD Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically; multiple test samples fromeach of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Aug-26-2014 Zimmer; Inc. Endo & Unipolar Femoral Heads – Endo & Unipolar Femoral Heads:ENDO FEMORAL HEAD 43MM DIA; ENDO FEMORAL HEAD 53MM DIA; ENDO FEMORAL HEAD 47MM DIA; ENDO FEMORAL HEAD 50MM DIA; ENDO FEMORAL HEAD 42MM DIA; ENDO FEMORAL HEAD 54MM DIA; ENDO FEMORAL HEAD 48MM DIA; ENDO FEMORAL HEAD 41MM DIA; ENDO FEMORAL HEAD 42MM DIA; ENDO FEMORAL HEAD 43MM DIA; ENDO FEMORAL HEAD 44MM DIA; ENDO FEMORAL HEAD 45MM DIA; ENDO FEMORAL HEAD 46MM DIA; ENDO FEMORAL HEAD 47MM DIA; ENDO FEMORAL HEAD 48MM DIA; ENDO FEMORAL HEAD 49MM DIA; ENDO FEMORAL HEAD 50MM DIA; ENDO FEMORAL HEAD 51MM DIA; ENDO FEMORAL HEAD 52MM DIA; ENDO FEMORAL HEAD 53MM DIA; ENDO FEMORAL HEAD 54MM DIA; ENDO FEMORAL HEAD 55MM DIA Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically; multiple test samples fromeach of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Aug-26-2014 Curbell Medical; Inc. CareSense Monitor – CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor; MODEL # CSM-BC400; — COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor — Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed; chair; floor mat; or toilet seat. The monitor will sound an alarm. The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer; it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However; this modification rendered the monitor's alarm via t

Aug-26-2014 Zimmer; Inc. Endo & Unipolar Femoral Heads – Endo & Unipolar Femoral Heads:ENDO FEMORAL HEAD 41MM DIAENDO FEMORAL HEAD 42MM DIAENDO FEMORAL HEAD 43MM DIAENDO FEMORAL HEAD 44MM DIAENDO FEMORAL HEAD 45MM DIAENDO FEMORAL HEAD 46MM DIAENDO FEMORAL HEAD 47MM DIAENDO FEMORAL HEAD 48MM DIAENDO FEMORAL HEAD 49MM DIAENDO FEMORAL HEAD 50MM DIAENDO FEMORAL HEAD 51MM DIAENDO FEMORAL HEAD 52MM DIAENDO FEMORAL HEAD 53MM DIAENDO FEMORAL HEAD 54MM DIAENDO FEMORAL HEAD 55MM DIAENDO FEMORAL HEAD 57MM DIAENDO FEMORAL HEAD 60MM DIAENDO FEMORAL HEAD 63MM DIAENDO FEM HEAD 41MMENDO FEM HEAD 42MMENDO FEM HEAD 43MMENDO PROS HEAD 44MMENDO FEM HEAD 45MMENDO FEM HEAD 46MMENDO FEM HEAD 47MMENDO FEM HEAD 48MMENDO FEM HEAD 49MMENDO FEM HEAD 50MMENDO FEM HEAD 51MMENDO FEM HEAD 52MMENDO FEM HEAD 53MMENDO FEM HEAD 54MMENDO FEM HEAD 55MMENDO FEM HEAD 57MMENDO FEM HEAD 60MMENDO FEM HEAD 63MMUNIPOLAR COMPONENT; 41MMUNIPOLAR COMPONENT; 42MMUNIPOLAR COMPONENT; 43MMUNIPOLAR COMPONENT; 44MMUNIPOLAR COMPONENT; 45MMUNIPOLAR COMPONENT; 46MMUNIPOLAR COMPONENT; 47MMUNIPOLAR COMPONENT; 48MMUNIPOLAR COMPONENT; 49MMUNIPOLAR COMPONENT; 50MMUNIPOLAR COMPONENT; 51MMUNIPOLAR COMPONENT; 52MMUNIPOLAR COMPONENT; 53MMUNIPOLAR COMPONENT; 54MMUNIPOLAR COMPONENT; 55MMUNIPOLAR COMPONENT; 56MMUNIPOLAR COMPONENT; 57MMUNIPOLAR COMPONENT; 58MMUNIPOLAR COMPONENT; 59MMUNIPOLAR COMPONENT; 60MM Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically; multiple test samples fromeach of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Aug-26-2014 Zimmer; Inc. Trauma Tubes and Plates – Trauma Tubes and Plates:TUBE & SCP PLT 90DX150LGTUBE & SCP PLT 90DX205LGTUBE & SCP PLT 90DX255LGTUBE & SCP PLT 95DX150LGTUBE & SCP PLT 95DX205LGTUBE & SCP PLT 95DX255LGTUBE&SCP PLT 130DX8HTUBE&SCP PLT 130DX10HTUBE&SCP PLT 130DX12HTUBE&SCP PLT 130DX14HTUBE&SCP PLT 135DX8HTUBE&SCP PLT 135DX10HTUBE&SCP PLT 135DX12HTUBE&SCP PLT 135DX14HTUBE&SCP PLT 140DX8HTUBE&SCP PLT 140DX10HTUBE&SCP PLT 140DX12HTUBE&SCP PLT 140DX14HTUBE&SCP PLT 145DX8HTUBE&SCP PLT 145DX10HTUBE&SCP PLT 145DX12HTUBE&SCP PLT 145DX14HTUBE&SCP PLT 150DX6HTUBE&SCP PLT 150DX8HTUBE&SCP PLT 150DX10HTUBE&SCP PLT 150DX12HTUBE&SCP PLT 150DX14HVERSA-FX II SC TUBE PLT 90DX6HVERSA-FX II SC TUBE PLT 90DX8HVERSA-FXII SC TUBE PLT 90DX10HVERSA-FXII SC TUBE PLT 90DX12HVERSA-FXII SC TUBE PLT 90DX14HVERSA-FXII SC TUBE PLT 95DX6HVERSA-FXII SC TUBE PLT 95DX8HVERSA-FXII SC TUBE PLT 95DX10HVERSA-FXII SC TUBE PLT 95DX12HVERSA-FXII SC TUBE PLT 95DX14HVERSA-FX KEYLESS 90D X 8HOLEVERSA-FX KEYLESS 90D X 11HOLEVERSA-FX KEYLESS 95D X 8HOLEVERSA-FX KEYLESS 95D X 11HOLEVERSA-FX KEYLESS 95D X 14HOLEVERSA-FX II STD TUBE 130DX8HVERSA-FX II STD TUBE 130DX10HVERSA-FX II STD TUBE 130DX12HVERSA-FX II STD TUBE 130DX14HVERSA-FX II STD TUBE 135DX8HVERSA-FX II STD TUBE 135DX10HVERSA-FX II STD TUBE 135DX12HVERSA-FX II STD TUBE 135DX14HVERSA-FX II STD TUBE 140DX8HVERSA-FX II STD TUBE 140DX10HVERSA-FX II STD TUBE 140DX12HVERSA-FX II STD TUBE 140DX14HVERSA-FX II STD TUBE 145DX8HVERSA-FX II STD TUBE 145DX10HVERSA-FX II STD TUBE 145DX12HVERSA-FX II STD TUBE 145DX14HVERSA-FX II STD TUBE 150DX8HVERSA-FX II STD TUBE 150DX10HVERSA-FX II STD TUBE 150DX12HVERSA-FX II STD TUBE 150DX14HVERSA-FX II KEYLESS TB 130DX8HVERSA-FX II KEYLESS TB 135DX8HVERSA-FX II KEYLESS TB 140DX8HVERSA-FX II KEYLESS TB 145DX8HVERSA-FX II KEYLESS TB 150DX8HVERSA-FX KEYLESS 90D X 8HOLEVERSA-FX KEYLESS 90D X 11HOLEVERSA-FX KEYLESS 95D X 8HOLEVERSA-FX KEYLESS 95D X 11HOLEVERSA-FX KEYLESS 95D X 14HOLE Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically; multiple test samples fromeach of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Aug-26-2014 Zimmer; Inc. Knee Instrument Fixation Screws – Knee Instrument Fixation Screws:48MM HEADED SCREW 48MM HEADLESS SCREWMIS HEADED SCREW; 48MMMIS HEADLESS SCREW; 48MM Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically; multiple test samples fromeach of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Aug-26-2014 Zimmer; Inc. Knee Stem Extensions & Impactor Sleeve – Knee Stem Extensions & Impactor Sleeve:STEM IMPLANT 20MMDX145MMSTEM IMPLANT 22MMDX145MMSTEM IMPLANT 24MMDX145MMSHARP FLUTED ST 20MMDX75MMSHARP FLUTED ST 22MMDX75MMSHARP FLTD ST 24MMDX75MMSHARP FLUTED ST 20MMDX130MMSHARP FLUTED ST 22MMDX130MMSHARP FLUTED ST 24MMDX130MMCEMENTED STEM EXT 13MM X 145MMIMPACTOR SLEEVE*NGK STEM EXT 12X245MM (200MM)NGK STEM EXT 13X245MM (200MM)NGK STEM EXT 14X245MM (200MM)NGK STEM EXT 15X245MM (200MM)NGK STEM EXT 16X245MM (200MM)NGK STEM EXT 17X245MM (200MM)NGK STEM EXT 18X245MM (200MM)NGK STEM EXT 20X245MM (200MM)NGK STEM EXT 22X245MM (200MM)SMOOTH REV STM 9.5MM X 19SMOOTH REV STM 11.5MM X 1SMOOTH REV STM 13.5MM X 1SMOOTH REV STM 15.5MM X 1SMOOTH REV STM 17.5MM X 1REV FEM STM 10.5MM X 200MREV FEM STM 12.5MM X 200MREV FEM STM 14.5MM X 200MREV FEM STM 16.5MM X 200M18.5X200MM REV STEMREV FEM STM 10.5MM X 250MREV FEM STM 12.5MM X 250MREV FEM STM 14.5MM X 250MREV FEM STM 16.5MM X 250M12.5X155MM FLUTED OFFST R14.5X155MM FLUTED OFFST R16.5X155MM FLUTED OFFST R18.5X155MM FLUTED OFFST R20.5X155MM FLUTED OFFST R12.5X175MM FLUTED REV STMFLUTE REV STEM – 14.5MM XFLUTE REV STEM – 16.5MM XFLUTE REV STEM – 18.5MM XFLUTE REV STEM – 20.5MM XFLUTE REV STEM – 22.5MM XFLUTED REV STM 10.5MM X 1FLUTED REV STM 11.5MM X 1FLUTED REV STM 12.5MM X 1FLUTED REV STM 13.5MM X 1FLUTED REV STM 14.5MM X 1FLUTED REV STM 16.5MM X 1FLUTED REV STM 18.5MM X 1 Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically; multiple test samples fromeach of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Aug-26-2014 Siemens Healthcare Diagnostics; Inc. Siemens Dimension EXL Chemistry System – Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929; 10636928; 10486890; 10472176; 10639337; and 10639338.

Aug-27-2014 Thermedx LLC Thermedx Fluid Management System – The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate; distend; and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant. A vendor changed the manufacturing process of a component used in teh canister ring that may affect the performance of the ring. The deficit display may be higher than the acutal deficit when the fluid collection canister is fully loaded.

Aug-28-2014 Cordis Corporation EMPIRA (TM) RX PTCA Dilatation Catheter – Cordis EMPIRA RX PTCA Dilatation Catheter Cordis Corporation and Creganna-Tactx Medical have observed that the balloon of their products Cordis EMPIRA (Trade Mark) NC RX PTCA Dilatation Catheter and Cordis EMPIRA (Trade Mark) RX PTCA Dilatation Catheter; which are covered with a hydrophilic coating; may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may

Aug-28-2014 Cordis Corporation EMPIRA (TM) NC RX PTCA Dilatation Catheter – Cordis EMPIRA NC RX PTCA Dilatation Catheter Cordis Corporation and Creganna-Tactx Medical have observed that the balloon of their products Cordis EMPIRA (Trade Mark) NC RX PTCA Dilatation Catheter and Cordis EMPIRA (Trade Mark) RX PTCA Dilatation Catheter; which are covered with a hydrophilic coating; may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may

Aug-28-2014 Civco Medical Instruments Inc CollectEVAC – CollectEVAC; Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO.The product is intended to be used to perform irrigation; tissue collection; and/or straining functions during transurethral prostate or bladder surgery. A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.Aug-29-2014 OrthoPediatrics Corp Sleeve Installation Tool Instrument – ACL Sleeve Installation Tool Sizes: 6mm; 6.5mm; 7.0mm; 7.5mm; 8.0mm; 8.5mm; 9.0mm; 10.0mmProduct Usage:The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone. Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.

Filed Under: Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance