medical Class II Updated 2020-04-01

Karl Storz Endoscopy recalls Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005B

Recalled Product

Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1

Hazard / Issue

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.

Issued by

FDA

Affected States: 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

Lot/Code Info: All Lots

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