Recall Z-1407-2023 ยท HFX Clamp, Circumcision
MEDLINE INDUSTRIES, LP - Northfield
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
| Date | Apr 19, 2023 (initiated Mar 2, 2023) |
| Status | Open, Classified |
| Reason | The CirClamp subassembly found in the kit was the incorrect size. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated 3/2/2023 via first class mail informing the consignee of the issue and to remove it from stock and dispose of it. The letter provided required actions which again included destroying the affected product and to return the completed enclosed destruction form listing the quantity of affected product destroyed. Once the destruction form is received, the account will be issued a credit. If the device has been transferred to another individual, department or location, the consignee is to notify them of this recall communication. |
| Quantity | 162 units |
| Distribution | US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890897 | CENTURION CIRCLAMP Tri-State Hospital Supply Corp., Mar 28, 1989 |