Reported Apr 20, 2016 · Terminated
Catalog Number: 900281A LAPAROTOMY 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 Number900281A LAPAROTOMY 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
- LOTSSL15194 (150719776) 31-JUL-16 SL15197 (150719778) 31-JUL-16 SL15199 (150719777) 31-JUL-16 SL15201-01 (150719777) 31-JUL-16 SL15217 (150720038) 31-AUG-16 SL15219 (150720039) 31-AUG-16 SL15222 (150720039) 31-AUG-16 SL15222 (150720038) 31-AUG-16 SL15225 (150720040) 31-AUG-16 SL15231 (150720040) 31-AUG-16 SL15271 (150920908) 30-SEP-16 SL15271 (150920640) 30-SEP-16
- Amount recalled
- 597
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.