Recall Z-2649-2023 ยท HFX Clamp, Circumcision
MEDLINE INDUSTRIES, LP - Northfield
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
| Date | Sep 29, 2023 (initiated May 23, 2023) |
| Status | Open, Classified |
| Reason | The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size. |
| Root cause | Process control |
| Action | The recalling firm issued letters dated 5/23/2023 via email and first class mail on 5/23/2023 to its consignees, which identified incorrect information regarding the affected product. It had stated the label indicates the kit contains a 1.3 cm bell and insert; however the kit actually contains a 1.45 cm bell and insert. The affected kits were to be destroyed for credit and none were to be returned to the recalling firm. The consignee was to check their stock for the affected item number and lot numbers listed on the recalling firm's recall portal and destroy the affected product. A link wa |
| Quantity | 106 units |
| Distribution | US Nationwide 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 |