Recall Z-1702-2022— American Contract Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by American Contract Systems, Inc., initiated 2022-06-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Various hysterectomy, vaginal packs. Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures..
- Recalling firm
- American Contract Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-16
- Firm location
- Kansas City, MO, United States
Product description
Various hysterectomy, vaginal packs
Reason for recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Data sourced from openFDA. This site is unofficial and independent of the FDA.