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Customed, Inc recalls KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN SURG REINFORCED LARGE
Recalled September 10, 2014 · FDA recall Z-2458-2014 · 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
1lot/ 300 units
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
KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill (1) PRE PAD CUFF (1) COVER MAYO STAND REINFORCED (1) BAG SUTURE FLORAL (1) SHEET SPLIT WITH/ADHESIVE 108" X 77" STD SMS (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) STRIPS TAPE 24" X 4" (1) DRAPE ARTHROSCOPY W/POUCH (1) TOWEL 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 →