Reported Oct 3, 2018 · Terminated
Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part…
CooperSurgical, 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: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
Retractor System Elastic Stays (Part 3314-lG3316-lG3550-lG)
- Product UsageThe Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures
- Lot codes and dates
Lots 244660245964250426251395244667244883244884245603245973246138& 248871
- Amount recalled
- 18,000 units
Where it was sold
Why it was recalled
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
This product could cause temporary or reversible health problems — stop using it.
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