Z-0274-2023Class II

BASIN SET, MEBS42K, general surgical kit

Name: Z-0274-2023 BASIN SET, MEBS42K, general surgical kit
Creator: American Contract Systems, Inc.
Published: 2022-10-12
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2022-10-12 / Terminated / root cause: manufacturing process

FDA source

American Contract Systems, Inc. began a recall of BASIN SET, MEBS42K, general surgical kit on 2022-10-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0274-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-12
Posted: 2022-11-22
Terminated: 2025-03-06
Recalling firm: American Contract Systems, Inc.
Product: BASIN SET, MEBS42K, general surgical kit
Product code: LRO General Surgery Tray
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.
Root cause tag: manufacturing process
FDA 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 [email protected] for a replacement kit."
Quantity in commerce: 1504 trays
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0274-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0274-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-22

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)