FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

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
Brand
Aesculap Implant Systems LLC
UPC
Material Code MG096R (1.1 CM) MG097R (1.3 CM) MG227 (1.45CM) MG228 (1.6CM) MG229 (2.1 CM) MG230 (2.6CM)

Units Affected

437 units