Recall Z-0274-2023 ยท LRO General Surgery Tray
American Contract Systems, Inc.
BASIN SET, MEBS42K, general surgical kit
| Date | Nov 22, 2022 (initiated Oct 12, 2022) |
| Status | Terminated |
| Reason | Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label. |
| Root cause | Employee error |
| Action | The firm issued an URGENT: MEDICAL DEVICE FIELD CORRECTION notice to their consignees by email on 10/12/2022. The notice explained the issue and requested the following actions be taken: "Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this product recall and maintain records of effectiveness. If you received any of the batches listed in this notification letter, please contact Breah.Waldridge@owens-minor.com for a replacement kit." |
| Quantity | 1504 trays |
| 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.