Recall Z-1333-2016 ยท MNL Accessories, Cleaning Brushes, For Endoscope
Karl Storz Endovision, Inc.
ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
| Date | Feb 29, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| 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 |
| Quantity | 16908 brushes |
| Distribution | Nationwide Foreign: Canada, Mexico, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.