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www.fdanews.com/articles/124182-deadline-to-stop-using-ss1-extended

Deadline to Stop Using SS1 Extended

February 2, 2010
Healthcare professionals should stop using Steris’ System 1 (SS1) processor and switch to a legally marketed device within 18 months, the FDA says, extending its original deadline of 3 to 6 months. Steris chose not to seek clearance of the device, which is misbranded and adulterated, according to the agency. The FDA issued a MedWatch in December for the SS1, alerting healthcare providers to the risk of burns following exposure to a sterilant solution.