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Karl Storz Endoscopy recalls Karl Storz, Model # 11161C2, Flexible Neuroscope
Recalled April 1, 2020 · FDA recall Z-1531-2020 · Karl Storz Endoscopy
Hazard
During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed. · FDA Class II
Units
42 scopes
Sold at
US: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV, OUS: Canda
Description
During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
Product
Karl Storz, Model # 11161C2, Flexible Neuroscope
Manufacturer(s)
Karl Storz Endoscopy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →