BASIN SET, MEBS42K, general surgical kit
FDA device recall Z-0274-2023 · posted 2022-11-22 · Terminated
Recall details
- Recalling firm
- American Contract Systems, Inc.
- Reason for recall
- 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.
- Action taken
- 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."
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 1504 trays
- Distribution
- US Nationwide distribution.
- Date initiated
- 2022-10-12
- Date posted
- 2022-11-22
- Date terminated
- 2025-03-06
- Location
- Kansas City, MO
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