Recall Z-0274-2023
American Contract Systems, Inc. · initiated October 12, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BASIN SET, MEBS42K, general surgical kit
Codes / lots: UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023
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.
FDA-determined cause: Employee error
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."
Details
- Recall number
- Z-0274-2023
- Initiated
- October 12, 2022
- Posted by FDA
- November 22, 2022
- Terminated
- March 6, 2025
- Product code
- LRO – General Surgery Tray
- Quantity
- 1504 trays
- Distribution
- US Nationwide distribution.
- Recalling firm
- American Contract Systems, Inc., Kansas City, MO