Reported Apr 20, 2016 · Terminated
Catalog Number: 900063 WOUND CLOSURE TRAY I 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 Number900063 WOUND CLOSURE TRAY I 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
- LOTSSL15169 (150317576) 28-FEB-16 SL15169 (150619102) 31-MAY-16 SL15169 (150518600) 31-MAY-16 SL15170 (150518600) 31-MAY-16 SL15173 (150619102) 31-MAY-16 SL15175 (150418229) 31-MAY-16 SL15199 (150719614) 31-MAY-16 SL15203 (150719614) 31-MAY-16 SL15225 (150719614) 31-MAY-16 SL15231 (150820140) 31-AUG-16 SL15243 (150820140) 31-AUG-16 SL15251 (150820140) 31-AUG-16 SL15272 (150920663) 30-SEP-16 SL15273 (150920663) 30-SEP-16
- Amount recalled
- 4550
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Customed, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.