American Contract Systems recalled 32,433 radiology packs on September 4, 2025, due to improper sterilization. The products were re-gassed after a nonconformance in the initial Ethylene Oxide gas injection process. Their safety and effectiveness remain unverified 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 the LKRA40G Radiology Pack. These kits were distributed nationwide in states including South Dakota, Iowa, Minnesota, Washington, and Illinois.
The products were not validated for exposure to multiple sterilization cycles, which raises significant safety concerns. Quality, safety, and effectiveness cannot be assured for the re-gassed items.
No specific injuries or incidents have been reported related to this recall. The potential risks associated with improper sterilization could pose serious health threats to patients.
Stop using the radiology packs immediately. Follow the recall instructions provided by the manufacturer and contact American Contract Systems or your healthcare provider for further guidance.
For assistance, contact American Contract Systems Inc. directly. Additional information can be found on the FDA website.
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