American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The kits were re-gassed after a noncompliance during the Ethylene Oxide sterilization process. This raises concerns about their safety and effectiveness.
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 medical convenience kits with model number IHDC30R UDI-DI 191072226310, specifically lot 8096511. These kits were distributed nationwide in South Dakota, Iowa, Minnesota, Washington, and Illinois.
The affected products were re-gassed after failing the initial sterilization process. These kits have not been validated for multiple sterilization cycles, creating potential safety risks.
No specific incidents or injuries have been reported related to this recall. However, the potential for compromised product quality raises serious concerns.
Patients and healthcare providers should stop using the recalled kits immediately. Follow the recall instructions provided by American Contract Systems or contact your healthcare provider for further guidance.
For more information, contact American Contract Systems Inc. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0187-2026.
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