BEUDAMED
    FDA Enforcement Class II Terminated

    Flexible Intubation Fiberscope, Model # 11301AB1

    Recall: Z-2447-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2447-2019
    Event ID
    83419
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    April 24, 2019
    Classification Date
    August 31, 2019
    Termination Date
    December 4, 2020
    Address
    2151 E Grand Ave, N/A, El Segundo, CA, 90245-5017, United States

    Description

    Flexible Intubation Fiberscope, Model # 11301AB1

    Reason

    The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.

    Code Info

    Lot numbers: 2183827, 2195794, 2215741, 2229258, 2235373, 2248169, 2193769

    Distribution

    US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada

    Quantity

    14 scopes