Recall Z-0274-2023— American Contract Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by American Contract Systems, Inc., initiated 2022-10-12, terminated 2025-03-06. FDA's recall record names no specific 510(k) clearance for this event. Product: BASIN SET, MEBS42K, general surgical kit. Reason: 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..
- Recalling firm
- American Contract Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-10-12
- Terminated
- 2025-03-06
- Firm location
- Kansas City, MO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.