American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. These kits failed to meet safety standards due to improper sterilization processes. The recall affects multiple states, including South Dakota and Iowa.
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 various medical convenience kits such as the LEFT HEART CATH PACK (Item Number EVLH67F) and others. The affected products were distributed nationwide in states including SD, IA, MN, WA, and IL.
The products were re-gassed after a nonconformance during the Ethylene Oxide gas injection process. These items have not been validated for exposure to multiple sterilization cycles, raising concerns about their quality and effectiveness.
No specific injuries or incidents have been reported. However, the risk associated with using these unvalidated sterilized products remains high.
Stop using the recalled medical kits immediately. Follow the recall instructions provided by the manufacturer and contact American Contract Systems for further information.
For further details, contact American Contract Systems at the phone number provided in the recall notification. Additional information can be found on the FDA website.
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