BEUDAMED
    FDA Recall 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 · Initiated February 29, 2016

    Recall

    Recall Number
    Z-1333-2016
    Event Number
    72921
    Firm
    Karl Storz Endovision, Inc.
    FEI Number
    1221826
    Product Code
    MNL
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 29, 2016
    Terminated
    September 28, 2016
    Address
    91 Carpenter Hill Rd, Charlton, MA, 01507-5274

    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.

    Action

    Karl Storz issued Recall Letter to users on 12/23/15. Firm's letter: KARL STORZ has identified a replacement brush; model 11276CL2 that is now available to clean your endoscope. Please check your inventory and remove any model 11276CL brushes. These brushes must be returned to KARL STORZ. Please complete the attached form and followthe return instructions. Upon receipt of any 11276CL brushes from you we will provide you the 11276CL2 cleaning brush as replacement at no charge. Contact Lynn Carter, Director Quality Assurance at 508-248-9011, extension 1664 Monday through Friday, 8:00AM to 4:30PM, Eastern Time.

    Distribution

    Nationwide Foreign: Canada, Mexico,

    Quantity

    16908 brushes