Recall Z-0947-2017 ยท HFX Clamp, Circumcision
Aesculap Implant Systems LLC
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
| Date | Oct 28, 2016 |
| Status | Terminated |
| Reason | Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps. |
| Root cause | Under Investigation by 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. |
| Quantity | 437 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.