Home / Recalls / Medical Devices
American Contract Systems, Inc. recalls Various ENT Packs
Recalled September 14, 2022 · FDA recall Z-1693-2022 · American Contract Systems
Hazard
Product was exposed to multiple sterilization cycles without validation for multiple exposures. · FDA Class II
Units
3 units
Sold at
Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Description
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Product
Various ENT Packs
Manufacturer(s)
American Contract Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →