American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The recall stems from products being re-gassed after a nonconformance during sterilization. This compromises the quality and safety of the devices.
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 models such as ANSH14AF Shoulder Pack and EVAH76H Anterior Hip Pack. The products were distributed nationwide in states including SD, IA, MN, WA, and IL. They were sold at multiple retailers.
The affected products were re-gassed after failing the initial Ethylene Oxide gas injection process. These products have not been validated for safety after multiple sterilization cycles.
No specific incidents or injuries have been reported related to this recall. However, the risk associated with unvalidated sterilization poses a high concern.
Stop using the recalled medical kits immediately. Contact American Contract Systems or your healthcare provider for further instructions on the recall process.
For more information, call American Contract Systems or visit their website. Detailed recall instructions are also available in the notification letter.
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