Aesculap Implant Systems product recalled over sterility concerns

Recall date

October 28, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Aesculap Implant Systems LLC recalls Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The…

Recall number

Z-0947-2017

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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