CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET 41" X 58" SMS LIF (1) BABY BLANKET PRINTED LIF (1) BOWL PLASTIC 80oz WITH LID (1) TUBE SUCTION CONNECT.%" X 12' LIF (15) LAP SPONGES PREWASH XRD LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) PAD OBSTETRICAL X-LARGE ST. L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) SYRINGE 20cc SITIP LIF (1) FEEDING TUBE 8FR. 15" LONG (1) BABY BEANNIES LIF (1) DRESSING ISLAND 4" X 14" (1) DRAPE C-SECTION WITH POUCH 102" X 121" X 78" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" L/F (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SUTURE BAG FLORAL LIF (1) UMBILICAL CORD CLAMP (1) BLADE SURGICAL #20 CARBON STEEL (1) WRAPPER 24" X 24" L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2408-2014
- 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 - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET 41" X 58" SMS LIF (1) BABY BLANKET PRINTED LIF (1) BOWL PLASTIC 80oz WITH LID (1) TUBE SUCTION CONNECT.%" X 12' LIF (15) LAP SPONGES PREWASH XRD LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) PAD OBSTETRICAL X-LARGE ST. L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) SYRINGE 20cc SITIP LIF (1) FEEDING TUBE 8FR. 15" LONG (1) BABY BEANNIES LIF (1) DRESSING ISLAND 4" X 14" (1) DRAPE C-SECTION WITH POUCH 102" X 121" X 78" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" L/F (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SUTURE BAG FLORAL LIF (1) UMBILICAL CORD CLAMP (1) BLADE SURGICAL #20 CARBON STEEL (1) WRAPPER 24" X 24" L/F 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 900-1719, 23 lots: 111082259 111092364 111123379 112010086 112020404 112041199 112051873 112062447 112125292 113015635 113026050 113036756 113057398 113067894 113078273 113088759 113099390 113109748 131210760 140111171 140211792 140312084 140412458
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.
23 lots; 804 units (multiple units per lot)