FDA-Device2017-01-11Class II

Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries

Aesculap Implant Systems LLC
Hazard

Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.

Sold states
Nationwide Distribution
Affected count
437 units
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0947-2017

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