Reported Sep 9, 2015 · Terminated
GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care…
Customed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Lot codes and dates
- Code9002592
- Lots140915320 exp. 9/30/19 150116795 exp. 3/31/16 150217395 exp. 3/31/16 150317646 exp. 3/31/16 150317849 exp. 5/31/16 150317850 exp. 5/31/16 150317848 exp. 5/31/16 150418378 exp. 6/30/16
- Amount recalled
- 216
This recall covers 170 products
The agency filed one notice per product. You are reading one of them; the other 169 are below.
157 more are in the archive.
Where it was sold
Why it was recalled
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
This product could cause temporary or reversible health problems — stop using it.
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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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