Reported Apr 20, 2016 · Terminated
Catalog Number: 9002511 MINOR SURGICAL PACK 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?
- Catalog Number9002511 MINOR SURGICAL PACK 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
- LOTSSL15170 (150317841) 30-APR-16 SL15170 (150317843) 30-APR-16 SL15180 (150619260) 30-JUN-16 SL15184 (150317844) 30-APR-16 SL15199 (150719841) 31-JUL-16 SL15203 (150719841) 31-JUL-16 SL15229 (150820295) 31-AUG-16 SL15245 (150820296) 31-AUG-16 SL15246 (150820296) 31-AUG-16 SL15267 (150920885) 31-AUG-16 SL15268 (150920886) 31-AUG-16 SL15271 (150920887) 31-AUG-16 SL15273 (150920884) 31-AUG-16 SL15273 (150920809) 31-AUG-16
- Amount recalled
- 344
This recall covers 100 products
The agency filed one notice per product. You are reading one of them; the other 99 are below.
87 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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