Z-1333-2016 Class II Terminated
FDA device recall Z-1333-2016 was initiated by Karl Storz Endovision, Inc. on February 29, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated September 28, 2016). Affected quantity: 16908 brushes.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2016
- Initiation Date
- February 29, 2016
- Termination Date
- September 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16908 brushes
Product Description
ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
Reason for Recall
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.
Distribution Pattern
Nationwide Foreign: Canada, Mexico,
Code Information
All lot numbers