American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025, due to improper sterilization. The affected products were re-gassed and not validated for safety after multiple sterilization cycles. Distribution occurred nationwide, including states such as South Dakota and Illinois.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall includes the following models: HSAN63N, IHAN02W, MHCA98AK, RCAN45C, and UDCO10F. Products were distributed under various item numbers with UDI-DI codes. They were sold across the United States.
The products were re-gassed after a nonconformance during the initial Ethylene Oxide gas injection process. Their effectiveness and safety cannot be confirmed due to unvalidated exposure to multiple sterilization cycles.
No specific incidents have been reported. The recall is classified as Class II, indicating a potential high hazard.
Stop using the recalled medical kits immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems or your healthcare provider for more guidance.
For more information, contact American Contract Systems Inc. at their website or via the recall notification letter.
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