Reported Sep 10, 2014 · Terminated
0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42"…
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?
- 0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (1) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) BOWL PLASTIC WITH LID 80oz LIF (1) RECEIVING BLANKET 100% COTTON (1) BABY BLANKET IMPERVIOUS POLY ABS. LIF (1) UMBILICAL CORD CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) UTILITY BOWL 16oz LIF (2) TRAY ORGANIZER FULL DEEP (3) ABSORBENT TIP APPLICATOR (2) GLOVE EXAM MEDIUM (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP (10) GAUZE SPONGE 4" X 4" 12PLY (2) PAD OBSTETRICAL X-LARGE ST. LIF (1) EAR ULCER SYRINGE 2oz UF (1) BABY BEANNIES (2) DRAPE SHEET 41 " X 58" SMS (1) SCISSORS UMBILICAL (1) TABLE COVER REINFORCED 44" X 78" L/F (2) WRAPPER 24" X 24" LI EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
Product code 900-25422
- lots
111113093111123230112030815112041318112051972112093935112114665113026059113026113113036348113036461113047019113047218113057472113088799113089161113109797131110249131210793140312134140412465140412904
- Amount recalled
- 22 lots; 1485 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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