Recall Z-2518-2024— American Contract Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by American Contract Systems, Inc., initiated 2024-05-06. FDA's recall record names no specific 510(k) clearance for this event. Product: American Contract Systems Gyn Laparoscopy convenience kit. Reason: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility.
- Recalling firm
- American Contract Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-06
- Firm location
- Kansas City, MO, United States
Product description
American Contract Systems Gyn Laparoscopy convenience kit
Reason for recall
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.