Recall Z-0133-2025 ยท HFX Clamp, Circumcision
MEDLINE INDUSTRIES, LP - Northfield
(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile; (5) Centurion CirClamp with 1.1cm Bell, Reorder #310CR, Sterile; (6) Centurion CirClamp with 1.1cm Bell Reprocessed, Reord
| Date | Oct 18, 2024 (initiated Sep 3, 2024) |
| Status | Open, Classified |
| Reason | Product has been identified as having holes in the packaging. |
| Root cause | Device Design |
| Action | The recalling firm issued letters on and dated 9/3/2024 via first class mail or email. The letter explained the reason for recall and the required action, which included: (1) Immediately check your stock for the affected item and lot numbers which can be located within the recall portal and quarantine all affected product immediately; (2) Use the link and information in the letter to complete the response form to list the quantity of affected product in inventory; (3) Upon receipt of the response form, return labels will be provided; (4) If you are a distributor or have resold or transfer |
| Quantity | 498,354 kits |
| Distribution | Worldwide distribution - US Nationwide and the countries of India and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890897 | CENTURION CIRCLAMP Tri-State Hospital Supply Corp., Mar 28, 1989 |