American Contract Systems recalled the IHDC30R D AND C PACK medical convenience kits distributed nationwide in the United States. The recall stems from a nonconformance during Ethylene Oxide gas injection that led to re-gassing. The products have not been validated for exposure to multiple sterilization cycles. Health safety cannot be confirmed for re-gassed units. Stop using them and await recall
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 clinical settings. They are intended to support routine medical workflows and patient care.
Re-gassing after the EO sterilization process was not validated for multiple cycles. This raises concerns about the device meeting intended safety and effectiveness standards.
This recall is not presented as part of a broader industry pattern in the available information.
Hospitals and clinics may need to halt use of affected lots and coordinate with suppliers for replacement options. The recall may affect care delivery relying on these kits.
Recall notices, FDA enforcement page Z-0187-2026, and manufacturer instructions
No refunds info provided in the data; follow the recall notification by letter for guidance on next steps
Keep copy of recall notices, lot numbers, model numbers, and correspondence with manufacturer
IHDC30R D AND C PACK medical convenience kits. Model: IHDC30R UDI-DI 191072226310. Lot: 8096511. Bag serial: N/A (bag serial listed as N/A means the whole lot is affected). Sold in the US nationwide with distribution in SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Manufacturer: American Contract Systems Inc.
No injuries or incidents have been reported.
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