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Customed, Inc recalls OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) A
Recalled September 10, 2014 · FDA recall Z-2380-2014 · 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
1 lot; 30 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
OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK SPONGES (1) MEASURE DISP. PAPER TAPE 24" (1) IMP .REINFORCED GOWN XLge. SMS STERILE (1) TABLE COVER Reinf. L/Free (1) SYRINGE 1cc W/NDL. 25G X 5/8 SLIP TIP L/Free (2) PAD OBSTETRICAL XLGE ST. (1) UNDERBUTTOCK DRAPE W/POUCH (1) SYRINGE 10cc W/0 NDL. L/Free (1) SYRINGE 20cc W/ONDL. L/Lock L/Free (1) FEEDING TUBE 8 Fr. 15" LONG (1) BABY BLANKET IMP. POLY ABS. (1) NEEDLE HYPODERMIC 23GA X 1" (6) ABSORBENT TOWELS L/Free (1) WRAPPER 24" X 24" 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 →