BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1532-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1532-2020
    Event ID
    84896
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2020
    Initiation Date
    August 27, 2019
    Classification Date
    March 20, 2020
    Address
    2151 E Grand Ave, N/A, El Segundo, CA, 90245-5017, United States

    Description

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

    Reason

    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.

    Code Info

    All Lots

    Distribution

    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

    Quantity

    21 scopes