Reported Sep 9, 2015 · Terminated
PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical procedures and patient care procedures…
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?
- PREMIUM LAPAROTOMY PK CUSTOMED 6/CS 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
- Code9001296
- Lots140915095 exp. 2/28/19 141115975 exp. 11/30/15 150116734 exp. 1/31/16 150116736 exp. 2/28/16 150116737 exp. 2/28/16 150116739 exp. 2/28/16 150116738 exp. 2/28/16 150116735 exp. 2/28/16 150217232 exp. 2/28/16 150217230 exp. 2/28/16 150217233 exp. 2/28/16 150217234 exp. 3/31/16 150217235 exp. 3/31/16 150217231 exp. 3/31/16 150317683 exp. 3/31/16 150317684 exp. 3/31/16 150317685 exp. 3/31/16 150317686 exp. 4/30/16 150317687 exp. 4/30/16 150418285 exp. 4/30/16 150418286 exp. 4/30/16 150418287 exp. 4/30/16 150418288 exp. 4/30/16 150418289 exp. 4/30/16 150518634 exp. 5/31/16 150518635 exp. 5/31/16 150519022 exp. 5/31/16 150519023 exp. 5/31/16
- Amount recalled
- 508 packs
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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