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Customed, Inc recalls CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18"
Recalled September 10, 2014 · FDA recall Z-2343-2014 · Customed
Hazard
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. · FDA Class I
Units
47 lots; 5560 units (multiple units per lot)
Sold at
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.
Description
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
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.
Manufacturer(s)
Customed, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →