American Contract Systems recalled 32,433 medical convenience kits after multiple sterilization cycles compromised product safety. The recall, announced on September 4, 2025, stems from nonconformance during Ethylene Oxide gas sterilization. Affected products include kits used for cataract and eye procedures.
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 various medical convenience kits including the Cataract Pack (BFCT04X), Eye Pack (CMEY17AI), PEI Retinal Pack (PERP25AQ), and Vitrectomy Supply (UIVT47AS). These products were distributed nationwide across states including South Dakota, Iowa, Minnesota, Washington, and Illinois.
The recalled products were re-gassed after an initial sterilization failure. This process is not validated for safety or effectiveness, raising concerns over potential contamination or compromised quality.
No specific incidents or injuries have been reported related to this recall. The potential risk for patients using these kits is categorized as high due to the compromised sterilization.
Patients and healthcare providers should stop using the recalled kits immediately. Follow the recall instructions provided by the manufacturer and contact American Contract Systems or a healthcare provider for further guidance.
For more information, contact American Contract Systems at their customer service number or visit their website. Additional information can be found on the FDA's recall page.
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