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American Contract Systems Inc. recalls Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PAC
Recalled October 22, 2025 · FDA recall Z-0174-2026 · American Contract Systems
Hazard
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. · FDA Class II
Units
32,433 total
Sold at
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Description
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Product
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
Manufacturer(s)
American Contract Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →