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Customed, Inc recalls LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO STAND REINFORCED UF (2) TOW
Recalled September 10, 2014 · FDA recall Z-2330-2014 · 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
19 lots; 550 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
LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO STAND REINFORCED UF (2) TOWEL ABSORBENT 15" X 20" UF (1 0) GAUZE SPONGES XRD 4" X 4"-12PL Y (2) DRAPE SHEET 41 " X 58" SMS UF (4) DRAPE UTILITY WITH TAPE L/F 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 →