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Recall Observatory FDA recall evidence

Device product

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

Z-1333-2016

February 29, 2016

Class II

Product summary

Firm
Karl Storz Endovision, Inc.
Event
Event 72921
Status
Terminated
Classification
Class II
Quantity
16908 brushes
Official record key
device-enforcement:Z-1333-2016

Official wording

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 information: All lot numbers

Distribution pattern: Nationwide Foreign: Canada, Mexico,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.