PlainRecalls
FDA Devices Critical Class I Terminated

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) ABSORB

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2405-2014

Product Description

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 CLAMP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Reason for Recall

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.

Details

Recalling Firm
Customed, Inc
Units Affected
20 lots; 1095 units (multiple units per lot)
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Location
Fajardo, PR

Frequently Asked Questions

What product was recalled?
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 CLAMP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Recalled by Customed, Inc. Units affected: 20 lots; 1095 units (multiple units per lot).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 10, 2014. Severity: Critical. Recall number: Z-2405-2014.