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American Contract Systems, Inc. recalls Cath Lab Pack, CECL02P; Medical convenience kit
Recalled October 2, 2024 · FDA recall Z-3239-2024 · American Contract Systems
Hazard
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Description
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Product
Cath Lab Pack, CECL02P; Medical convenience kit
Manufacturer(s)
American Contract Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →