Recall Z-2367-2014— 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: OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) RECEIVING BLANKET 100% COTTON (1) PVP SCRUB 8" STICK SPONGE (1) FEEDING TUBE BFR, 15" LONG LIF (1) BOWL PLASTIC 80oz WITH LID (1) CORD UMBILICAL CLAMP (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 20cc SLIP TIP LIF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) NEEDLE HYPODERMIC 22G X 1% (20) GAUZE SPONGE 4" X 4" 16PL Y (1) EAR ULCER SYRINGE 2oz LIF (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" LIF (2) GLOVE MED FREETOUCH VYNIL POWDER FREE (1) WRAPPER 24" X 24" L/F (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL/WRAP 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

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