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/RULER EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Enforcement
- Recall Number
- Z-2320-2014
- 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
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/RULER 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 900-403, 30 lots: 112020525 112030955 112031372 112051682 112062486 112093590 112104107 112125170 112125315 113015449 113015695 113025960 113036485 113046957 113057479 113057817 113068169 113078573 113088813 113099289 113099571 131110076 131110409 131110586 131210970 140211667 140311937 140312382 140412836 140513246
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.
30 lots; 4396 units (multiple units per lot)