American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The products failed to meet sterilization standards, posing a safety risk. Healthcare providers and patients must stop using these kits immediately.
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 recalled medical convenience kits include models FHCP08Y, HICS50I, and HSCB90B. These items were distributed nationwide in states including South Dakota, Iowa, Minnesota, Washington, and Illinois.
These medical kits underwent multiple sterilization cycles without validation. This failure raises concerns regarding their quality, safety, and effectiveness.
No specific incidents or injuries have been reported related to these products. However, the lack of validation for re-gassed kits presents a high risk.
Stop using the recalled medical kits immediately. Follow the instructions provided by the manufacturer or contact your healthcare provider for further guidance.
For questions, contact American Contract Systems Inc. Additional information is available on the FDA website.
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