Recall Z-1408-2022 ยท OHM Cesarean Section Tray
ROi CPS LLC
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
| Date | Jul 19, 2022 (initiated Jun 3, 2022) |
| Status | Terminated |
| Reason | Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. |
| Root cause | Process change control |
| Action | The recalling firm initiated the recall via telephone on 6/3/2022 to the direct consignee of Item 830019017, explained the reason for recall, and instructed the product be quarantined. The recalling firm also contacted the end user who had received distribution from the direct consignee. The end user was informed of the error and was requested to remove the affected lot from their inventory. The recalling firm worked with the end user to have the kits returned to the direct consignee where they were placed in quarantine. Regarding the recall of Item #830099008 and Item #830014016, the dire |
| Quantity | 40 kits |
| Distribution | Distribution was made to MO. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.