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American Medical Systems Innovation Center - Silicon Valley Recalls
32 recalls on record · July 29, 2015 to July 29, 2015 · Medical Devices
July 29, 2015Medical DevicesFDA
American Medical Systems Innovation Center - Silicon Valley recalls Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applica
Hazard: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
July 29, 2015Medical DevicesFDA
American Medical Systems Innovation Center - Silicon Valley recalls Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applica
Hazard: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products