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Customed, Inc recalls PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN LARGE SMS IMPER
Recalled September 10, 2014 · FDA recall Z-2331-2014 · 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
60 lots; 4896 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
PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (1) DRAPE UNDERBUTTOCK WITH POUCH (1) UTILITY BOWL 16oz. (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) ROBNEL CATHETER 18FR. (1) DRAPE SHEET 41 " X 58" SMS (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UTILITY WITH TAPE 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 →