BASIN SET, MEBS42K, general surgical kit recallZ-0274-2023 · American Contract Systems, Inc. · initiated Oct 12, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from American Contract Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Employee error
What the company is doing
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 [email protected] for a replacement kit."
Recall details
- Recall number
- Z-0274-2023
- Status
- Terminated
- Initiated by the company
- Oct 12, 2022
- Posted by the FDA
- Nov 22, 2022
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 1504 trays
- Product code
- LRO
- Distribution
- US Nationwide distribution.
Product description
BASIN SET, MEBS42K, general surgical kit
Code information (models, lots, serial numbers)
UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ACS MEBS42KAmerican Contract Systems, Inc. · General surgery tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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