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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 Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket
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 Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket
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 Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket
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 Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket
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 Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket of
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 Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket
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 Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket of
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 Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket
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 Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket of
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 Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket
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 Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket of
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 Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket
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 Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket of
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 Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket
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 Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket of
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 Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket
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 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endost
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 Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver
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 Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off th
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 Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off th
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 Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off th
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 Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off th
Hazard: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex'" 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 Fiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off th
Hazard: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex'" 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 Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off th
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 365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications,
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 200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications,
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 910 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 550 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 365 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 273 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