American Contract Systems is recalling 32,433 medical Angio Packs distributed nationwide in the United States. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process. Healthcare facilities and patients should stop using the devices and follow the manufacturer’s recall instructions.
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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These are medical convenience kits used in angiography procedures. The packs are designed to streamline interventional imaging workflows in hospital settings.
Re-gassing after EO sterilization means the devices may not have been validated for multiple sterilization cycles. This could compromise sterility and safety.
This recall is not part of a broader industry pattern.
Hospitals may need to quarantine affected packs and coordinate replacements. The recall is active and requires immediate attention from healthcare facilities.
FDA enforcement report Z-0180-2026 and the manufacturer recall notice linked in the enforcement action
Recall status is ACTIVE. Processing times for replacement or refunds will be provided by the manufacturer.
Keep a copy of the recall notice, model numbers, serial/date codes, and all correspondence with the manufacturer.
Model numbers: HSAN63N, IHAN02W, MHCA98AK, RCAN45C, UDCO10F. Description: Medical convenience kits and angiography packs. Distribution: US nationwide in SD, IA, MN, WA, IL. Sold from: Unknown. Price: Unknown. Quantity recalled: 32,433.
No injuries or incidents have been reported.
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