American Contract Systems Inc. recalls 32,433 medical convenience kits distributed nationwide to healthcare facilities in SD, IA, MN, WA, and IL. Re-gassed after a nonconformance occurred during Ethylene Oxide gas injection. The kits have not been validated for multiple sterilization cycles. Healthcare providers should stop using the devices immediately and follow 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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Medical convenience kits are intended to provide sterile packs for obstetric procedures, including cesarean sections. They are used in operating room or hospital settings by healthcare professionals.
Re-gassing after a nonconformance during EO sterilization may affect sterility, safety, and effectiveness. The products have not been validated for exposure to multiple sterilization cycles.
This recall is not described as part of a broader industry pattern in the provided information.
Hospitals may need to halt use of affected kits, re-check inventory, and coordinate with the manufacturer for guidance on replacements or refunds. Potential risk to patients if compromised sterility is used in procedures.
Refer to the recall notice and the FDA enforcement page for Z-0181-2026; manufacturer communications will include specifics.
Replacements or refunds, if offered, will be communicated by the manufacturer. Timeline varies by facility and recall response plan.
Keep the recall notice, supplier communications, inventory logs, and any returned items documentation for records.
Product: Medical convenience kits. Item Numbers: FHCP08Y (C SECTION PK), HICS50I (C-SECTION PACK), HSCB90B (C-SECTION BASIN PACK). UDI-DI: FHCP08Y 191072232724, HICS50I 191072212351, HSCB90B 191072141606. Lot numbers: 8216211, 8161711, 8083511. Quantity: 32,433 total. Sold to: Healthcare facilities nationwide. States listed for distribution: SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Status: ACTIVE. Manufacturer: American Contract Systems Inc. Recall number: Z-0181-2026. Distribution: US nationwide.
No injuries or incidents have been reported.
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