Recall Z-2407-2014— Customed, Inc

Class I FDA medical device recall by Customed, Inc, initiated 2014-05-20, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (2) LEGGINS W/7'' CUFF 30" X 42" (1) GOWN LARGE SMS IMPERVIOUS REINFORCED (3) TOWELS ABSORBENT 15" X 20" LIF (I) PAD OBSTETRICAL X-LARGE ST. (I) PACKING VAG JNAL 4" X 36" 8PL Y XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (I) UMBILICAL CORD CLAMP (1) BABY BLANKET PRINTED (2) EAR/ULCER SYRINGE 2oz. LIF (I) COVER SET UP 42" X 75" CLEARPOLY (1) DRAPE ABDOMINAL WITH TAPE L/F (1) BOWL WITH LID PLASTICS 80oz. L/F (1) SHEET DRAPE 41" X 58" SMS LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Reason: 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..

Recalling firm

Customed, Inc

Classification

Class I

Status

Terminated

Initiated

2014-05-20

Terminated

2017-08-14

Firm location

Fajardo, PR, United States

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