Recall Z-0121-2020 ยท HFX Clamp, Circumcision
Centurion Medical Products Corporation
Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR
| Date | Aug 28, 2019 |
| Status | Terminated |
| Reason | A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel. |
| Root cause | Process control |
| Action | Centurion Medical Products issued Notification via Certified Mail, Return Receipt on 8/28/19 to customers who received affected product. Letter states reason for recall, helath risk and action to take: identify inventory within your possession and cease use immediately. Complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of your response Centurion Representative will contact you regarding retrieval of the product from your facility, if required. Forward this |
| Quantity | 204 each |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890897 | CENTURION CIRCLAMP Tri-State Hospital Supply Corp., Mar 28, 1989 |