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 LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2385-2014
- Event ID
- 68536
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Customed, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 10, 2014
- Initiation Date
- May 20, 2014
- Classification Date
- August 29, 2014
- Termination Date
- August 14, 2017
- Address
- Calle Igualdad Final #7, Fajardo, PR, 00738, United States
Description
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 LIF 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.
Product code 900-1297, 44 lots: 109030542 110061517 110071663 110081957 110082065 110082132 110112605 110112866 110123051 110123066 111030563 111071760 111082184 111082268 111092487 111102647 111102672 111112928 111112962 111123334 112010034 112020327 112041184 112062405 112062406 112062582 112062620 112083387 112114633 112124935 113015426 113025935 113036315 113036450 113047324 113068144 113078692 113109719 131110167 131110596 131210959 140111406 140412596 140513080
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.
44 lots; 4670 units (multiple units per lot)