Reported Jan 11, 2017 · Terminated
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The…
Aesculap Implant Systems LLC
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: Aesculap Implant Systems LLC · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- Gomco Circumcision
- Clamps with separate O-Ring ComponentThe device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
- Lot codes and dates
- Material Code MG096R (1.1 CM) MG097R (1.3 CM) MG227 (1.45CM) MG228 (1.6CM) MG229 (2.1 CM) MG230 (2.6CM)
- Amount recalled
- 437 units
Where it was sold
- Nationwide
Why it was recalled
Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
This product could cause temporary or reversible health problems — stop using it.
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