PlainRecalls
FDA Devices Critical Class I Terminated

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 IMPERVIOU

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2427-2014

Product Description

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/f Product Usage: 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 differ 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
23 lots; 1396 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?
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/f Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Recalled by Customed, Inc. Units affected: 23 lots; 1396 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 differ 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-2427-2014.