Reported Sep 11, 2019 · Terminated
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Boston Scientific Corporation
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: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5
- cm Part Number72400161
- Lot codes and dates
- Lot Number23973023
- Amount recalled
- 1 unit
Where it was sold
Why it was recalled
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
This product could cause temporary or reversible health problems — stop using it.
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