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Customed, Inc recalls ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1)
Recalled September 10, 2014 · FDA recall Z-2452-2014 · 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
3 lots/240 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
ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) U-DRAPE 60" X 70" WfTAPE SPLIT (1) SHEET EXTREMITY ABS. 125" X 85" (1) GOWN SOFT SMS STD. XLGE SET IN SLEEVE (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" Product Usage: 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 →