American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide in SD, IA, MN, WA and IL. The devices were re-gassed after a nonconformance in the Ethylene Oxide sterilization process. The sterilization cycles have not been validated, so quality, safety and effectiveness cannot be confirmed. Consumers and healthcare providers should stop using the kits
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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These are sterile orthopedic surgical kits used as part of surgical procedures. They are designed to contain multiple components for specific operations.
Re-gassing after EO sterilization introduces uncertainty about sterility. Without validated exposure to multiple sterilization cycles, the safety and effectiveness of the kits cannot be guaranteed.
This recall is not indicated as part of a broader industry pattern.
Hospitals and clinics may need to replace affected kits. The recall may affect procurement and stock levels, with potential delays in procedures if replacements are not readily available.
Recall letter from American Contract Systems; FDA enforcement page linked in notice
Recall processing times are not specified; typical timelines range from weeks to months depending on replacements
Keep the recall letter, model numbers, serials, and any communications with the manufacturer; document any replacements or refunds
Model numbers and descriptions include AMEX26AA, ANSH14AF, EVAH76H, FDSA15M, GRTS90G, HGHI26G, HJTO25C, HNEX60L, IAHD53C, IASH65A, IHUE40AI, ILTJ47AA, LMHP14Z, LMSN44AE, MHHP25H, MHTH90AJ, MWAH32P, MWTK13AH, PLOR89H, RCUE81B. Sold nationwide in the United States, including SD, IA, MN, WA, IL. Specific price and sale dates are not provided.
No injuries or incidents have been reported.
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