Reported Sep 10, 2014 · Terminated
OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30"…
Customed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Customed, Inc · Calle Igualdad Final #7 · Fajardo, PR · 00738
Is this the product you have?
- 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.
- Lot codes and dates
Product code 900-103018
- lots
112041230112072809112093846112104130112114918113026212113036313113047310113057379113067853113078668113109703131110148131210674140111136140211630140311913140513060
- Amount recalled
- 18 lots; 1580 units (multiple units per lot)
This recall covers 233 products
The agency filed one notice per product. You are reading one of them; the other 232 are below.
220 more are in the archive.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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