BASIN SET, MEBS42K, general surgical kit
This recall has been terminated (originally issued November 22, 2022).
- Company
- American Contract Systems, Inc.
- Recall Initiated
- October 12, 2022
- Posted
- November 22, 2022
- Terminated
- March 6, 2025
- Recall Number
- Z-0274-2023
- Quantity
- 1504 trays
- Firm Location
- Kansas City, MO
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023
Root 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."