Recall Z-0435-2025 ยท OKV Obstetrical Kit
AVID Medical, Inc.
Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02
| Date | Nov 14, 2024 (initiated Sep 20, 2024) |
| Status | Open, Classified |
| Reason | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions |
| Root cause | Process control |
| Action | Avid Medical issued Urgent: Voluntary Medical Device Recall letter via email on 9/20/24. Letter states reason for recall, health risk and action to take: If you received any of the batches/lots identified in APPENDIX 1, please review your inventory, and discard the entire kit. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. Distributors: If any of the affected kits identified in Appendix 1 were further distributed, please ensure all end-users are appropriately notified of this produc |
| Quantity | 20 eaches |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.