FDA recall Z-0274-2023
American Contract Systems, Inc. · Class II · device
Product
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
US Nationwide distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2022-10-12
- Report date
- 2022-11-30
- Termination date
- 2025-03-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Kansas City, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0274-2023