Reported Apr 20, 2016 · Terminated
Catalog Number: 900921A C-SECTION 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 Number900921A C-SECTION 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
- LOTSSL15175 (150619191) 30-JUN-16 SL15177 (150619191) 30-JUN-16 SL15197 (150719813) 31-JUL-16 SL15199 (150719813) 31-JUL-16 SL15222 (150820354) 31-AUG-16 SL15222 (150820353) 31-AUG-16 SL15224 (150820353) 31-AUG-16 SL15225 (150820354) 31-AUG-16 SL15261 (150920717) 30-SEP-16 SL15261 (150920716) 30-SEP-16 SL15264 (150920716) 30-SEP-16
- Amount recalled
- 238
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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