Recall Z-2408-2014— 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: CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET 41" X 58" SMS LIF (1) BABY BLANKET PRINTED LIF (1) BOWL PLASTIC 80oz WITH LID (1) TUBE SUCTION CONNECT.%" X 12' LIF (15) LAP SPONGES PREWASH XRD LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) PAD OBSTETRICAL X-LARGE ST. L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) SYRINGE 20cc SITIP LIF (1) FEEDING TUBE 8FR. 15" LONG (1) BABY BEANNIES LIF (1) DRESSING ISLAND 4" X 14" (1) DRAPE C-SECTION WITH POUCH 102" X 121" X 78" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" L/F (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SUTURE BAG FLORAL LIF (1) UMBILICAL CORD CLAMP (1) BLADE SURGICAL #20 CARBON STEEL (1) WRAPPER 24" X 24" L/F 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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