CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41" x 58" SMS LIF (2) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (1) SURGICAL BLADE #20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1) DRESSING ISLAND 4" X 1 0" (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) BABY BLANKET PRINTED (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) BAG SUTURE FLORAL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2343-2014
- 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- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41" x 58" SMS LIF (2) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (1) SURGICAL BLADE #20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1) DRESSING ISLAND 4" X 1 0" (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) BABY BLANKET PRINTED (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) BAG SUTURE FLORAL 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 900-660, 47 lots: 110061532 110071635 110071853 110102449 110112671 110122899 111010148 111020375 111030650 111040914 111051212 111061560 111071832 111082224 111092400 111102775 111112949 111123281 112010195 112020516 112030737 112041345 112052004 112062504 112083440 112093591 112093732 112114595 112125107 113015698 113025966 113036597 113036730 113057500 113057875 113068179 113088883 113099295 113109867 131110270 131110412 131110589 131210972 140111453 140211677 140211945 140513352
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.
47 lots; 5560 units (multiple units per lot)