DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the ...
Reason: Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-s...
Z-2595-2014September 17, 2014Salt Lake City, UT
CooperSurgical, Inc.
Class IITerminated
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Reason: Unsealed pouches.
Z-2570-2014September 17, 2014Trumbull, CT
Customed, Inc
Class ITerminated
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...
Reason: 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 th...
Z-2341-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (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 L...
Reason: 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 th...
Z-2453-2014September 10, 2014Fajardo, PR
Galt Medical Corporation
Class IITerminated
GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the periph...
Reason: The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Z-2588-2014September 10, 2014Garland, TX
Customed, Inc
Class ITerminated
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...
Reason: 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 th...
Reason: 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 th...
Z-2332-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
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 L...
Reason: 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 th...
Z-2436-2014September 10, 2014Fajardo, PR
Galt Medical Corporation
Class IITerminated
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intrav...
Reason: The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Reason: 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 th...
Z-2392-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
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"...
Reason: 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 th...
Reason: 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 th...
Z-2373-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
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) *RO...
Reason: 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 th...
Z-2328-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
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 HYPODE...
Reason: 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 th...
Z-2402-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
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...
Reason: 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 th...
Z-2365-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
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 ...
Reason: 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 th...
Z-2454-2014September 10, 2014Fajardo, PR
Datascope Corporation
Class IIITerminated
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
Reason: During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.
Z-2568-2014September 10, 2014Fairfield, NJ
Customed, Inc
Class ITerminated
FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (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 LU...
Reason: 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 th...
Z-2374-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
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) ...
Reason: 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 th...
Z-2370-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
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. (...
Reason: 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 th...
Z-2331-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
OPEN HEART TRAY PACK A CONTENTS: (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 9...
Reason: 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 p...
Z-2433-2014September 10, 2014Fajardo, PR
Ellex iScience, Inc.
Class IITerminated
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Reason: One lot may not have been properly sealed, resulting in a non-sterile device.
Reason: 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 th...
Z-2416-2014September 10, 2014Fajardo, PR
Customed, Inc
Class ITerminated
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 & LABE...
Reason: 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 th...
Reason: 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 a s...