Recall Z-1690-2022— American Contract Systems, Inc.

Name: FDA recall Z-1690-2022
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 Angiography/Cath Lab packs/trays. 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 Angiography/Cath Lab packs/trays

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.