Recall Z-1695-2022— American Contract Systems, Inc.

Name: FDA recall Z-1695-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-16

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 Cysto 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 Cysto 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.