BEUDAMED
    FDA Enforcement Class II Terminated

    ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL

    Recall: Z-1333-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1333-2016
    Event ID
    72921
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Karl Storz Endovision, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    February 29, 2016
    Classification Date
    April 5, 2016
    Termination Date
    September 28, 2016
    Address
    91 Carpenter Hill Rd, N/A, Charlton, MA, 01507-5274, United States

    Description

    ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL

    Reason

    Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel of the intended endoscope or to completely pass it through such channel.

    Code Info

    All lot numbers

    Distribution

    Nationwide Foreign: Canada, Mexico,

    Quantity

    16908 brushes