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Customed, Inc recalls BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILITY WITH TAPE UF (1) TOWEL ABSORBENT 15"
Recalled September 10, 2014 · FDA recall Z-2317-2014 · 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
38 lots; 2442 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
BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILITY WITH TAPE UF (1) TOWEL ABSORBENT 15" x 20" L/F (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS g~ SHEET o/. 57" X 63" REINFORCED SMS UF MAYO STAND COVER REINFORCED UF 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 →