ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use recalled over sterility concerns

Recall date

February 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Karl Storz Endovision, Inc. recalls ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endos…

Recall number

Z-1333-2016

FDA classification

Class II

Brand / firm

Karl Storz Endovision, Inc.

Sold / distributed

Nationwide Foreign: Canada, Mexico,

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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