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American Contract Systems, Inc. recalls American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience
Recalled August 14, 2024 · FDA recall Z-2519-2024 · American Contract Systems
Hazard
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 · FDA Class II
Units
120
Sold at
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
Description
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
Product
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
Manufacturer(s)
American Contract Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →