Recall Z-1703-2022 ยท OHM Cesarean Section Tray
American Contract Systems, Inc.
Various C-section packs
| Date | Jun 16, 2022 |
| Status | Open, Classified |
| Reason | Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| Root cause | Process change control |
| Action | The recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022. Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm. A Field Action Response Form should be completed and returned to angela.bunn@owens-minor.com as soon as possible, even if the customer has no inventory. If you hav |
| Quantity | 24 units |
| Distribution | Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.