American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The recall follows the identification of products that were re-gassed after sterilization failures. The safety and effectiveness of these products cannot be confirmed due to 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 following products: HEART PACK (ANCV78BC), CV SET UP PACK (HGCV05K), PACEMAKER PACK (MHPP97AR), BASIC HEART PACK (UDBH37AW), and others. These kits were distributed nationwide in South Dakota, Iowa, Minnesota, Washington, and Illinois.
The kits were found to have been sterilized more than once after a failure in the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for safety and effectiveness for multiple sterilization cycles.
No specific injuries or incidents have been reported related to this recall. The hazard level is classified as high due to the potential risks associated with using non-validated medical products.
Patients and healthcare providers must stop using these medical kits immediately. Follow the recall instructions provided by the manufacturer or contact American Contract Systems for further guidance.
For more information, contact American Contract Systems Inc. or visit the FDA recall notice at: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0176-2026.
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