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Customed, Inc recalls Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE
Recalled September 10, 2014 · FDA recall Z-2531-2014 · 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
25 lots/ 493 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
Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE L/Free (2) 3/4 ABS. REINFORCED SHEET (1) PLASTIC SHEET (5) DRAPE SHEET SMS (18) CLOTH HUCK TOWELS Blue (4) CLOTH HUCK TOWELS White (1 0) ABSORBENT TOWELS L/Free (4) GOWN IMP. BREATHABLE LGE. (3) MAYO STAND COVER L/Free (2) IMPERV. STOCKINETTE (1) WRAPPER 54" X 54" (1) TRAY PLATFORM LGE (1) TABLE COVER HD L/Free (1) WRAPPER 24" X 24" 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 →