BEUDAMED
    FDA Enforcement Class II Terminated

    FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

    Recall: Z-2425-2019 · Reported September 4, 2019

    Enforcement

    Recall Number
    Z-2425-2019
    Event ID
    83459
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 4, 2019
    Initiation Date
    February 20, 2019
    Classification Date
    August 28, 2019
    Termination Date
    July 7, 2020
    Address
    2151 E Grand Ave, N/A, El Segundo, CA, 90245-5017, United States

    Description

    FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

    Reason

    The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

    Code Info

    SERIAL NUMBER: 2161516, 2204079, 2172240, 2198276, 2062041, 2178784, 2198341, 2220959, 2210200, 2183837, 2188370, 2247464, 2248783, 2194154, 2244117, 2039298

    Distribution

    US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA

    Quantity

    22 scopes