American Contract Systems recalled 32,433 medical convenience kits nationwide in the United States after re-gassing sterilization cycles. The recall covers multiple packs including HEART PACK and PACEMAKER PACK with 2025 recall date. The safety issue centers on EO gasset validation failures after a nonconformance during initial gas injection. Stop using 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 kits used in clinical settings to supply cardiovascular procedures. They can include heart packs, CV setup packs, pacemaker packs, and vascular packs.
Re-gassing after EO sterilization may affect sterility and effectiveness. Validation for multiple cycles is lacking.
This recall is not part of a broader industry pattern.
Hospitals and clinics may need to quarantine affected lots and reassess inventory impact.
FDA enforcement page and recall notice; UDI-DI codes on packaging
Refunds or replacements processed through hospital procurement; typical timelines vary by institution
Keep product invoices, batch numbers, serials, and recall communications
Item numbers and descriptions include ANCV78BC HEART PACK 205947, HGCV05K CV SET UP PACK, MHPP97AR PACEMAKER PACK 206010, UDBH37AW BASIC HEART PACK 206044, UHPP82AH PERIPHERAL PACK 209533, UICD62AN CARDIOVASCULAR SUPPLY PS 907285, UICT16F CARDIO THORACIC DRAPE PACK PS 907284, UIVA75I VASCULAR PACK. Total quantity: 32,433 units. Distribution: US nationwide in SD, IA, MN, WA, IL.
No injury data provided in the recall notice. The FDA enforcement report lists the status as active with high hazard level.
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