Z-0274-2023 Class II Terminated
FDA device recall Z-0274-2023 was initiated by American Contract Systems, Inc. on Oct 12, 2022 and is designated Class II. 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. The recall status is terminated (terminated Mar 6, 2025). Affected quantity: 1504 trays.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 30, 2022
- Initiation Date
- Oct 12, 2022
- Termination Date
- Mar 6, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1504 trays
Product Description
BASIN SET, MEBS42K, general surgical kit
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 Pattern
US Nationwide distribution.
Code Information
UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0274-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026