Recall Z-1690-2023 ยท OHD Gynecological Laparoscopic Kit
Cardinal Health 200, LLC
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
| Date | Jun 6, 2023 (initiated Apr 6, 2023) |
| Status | Open, Classified |
| Reason | Inadvertently released for distibution without sterility assurance. |
| Root cause | Process control |
| Action | Cardinal Health initially notified customer on 04/06/2023, via telephone, on 04/12/2023, via email and followed up with a recall notification letter on 05/05/2023. Customer was instructed to return affected product. |
| Quantity | 5 units |
| Distribution | Distribution in the US to Georgia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.