American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025, after discovering re-gassing issues. The affected products have not been validated for safety and effectiveness after multiple sterilization cycles.
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 affects medical convenience kits including models BUCY78E, CMCP10X, IHCY10Y, MHCY35AE, PLBY52E, UDCY31Z, and UICY28L. These products were distributed nationwide across several states including South Dakota, Iowa, Minnesota, Washington, and Illinois.
The products were re-gassed after a nonconformance during the initial Ethylene Oxide gas injection process. Sterilization has not been validated for exposure to multiple cycles, raising concerns about quality and safety.
There are no specific reports of incidents or injuries associated with this recall. However, the re-gassing poses a high risk to patient safety.
Stop using these medical convenience kits immediately. Follow the manufacturer's recall instructions and contact American Contract Systems or your healthcare provider for further guidance.
For more information, contact American Contract Systems at the telephone number provided in the recall notification letter or visit the FDA recall website.
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