Recall Z-2382-2014— 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: PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WITH LID (10) LAP SPONGE PREWASH XRD LIF (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) EAR ULCER SYRINGE 2oz LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CORD UMBILICAL CLAMP LIF (1) DRESSING ISLAND 4" X 10" (1) BLADE SURGICAL#10 CARBON STEEL (1) BLADE SURGICAL#20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) C-SECTION DRAPE WITH POUCH (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III (1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAP 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.