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Terminated

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

FDA Recall Z-0947-2017 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeHFX
Date Initiated2016-10-28
Date Terminated2018-01-30
Product Quantity437 units

Reason for Recall

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

Firm Action

Aesculap sent an Urgent Medical Device Recall Notification letter dated October 28, 2016, to all affected customers were sent an Urgent Medical Device Recall Notification letter via Fed-Ex overnight.. Customers were asked to immediately remove the affect product from their inventory and return to Aesculap. A return label was provided to efficiently remove and return the affected products. Customers with questions should call 610-984-9414. For questions regarding this recall call 800-258-1946.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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