| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00951-1 |
| Product Name/Description |
Ureterorenoscope 8703-524 (rigid ureteroendoscope)
Serial Number: 5000262066
ARTG Number: 139254 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
The sleeve tube of the ureterorenoscope may break off when being used. This problem only occurs with specific serial numbers, one of which was supplied in Australia |
| Recall Action |
Recall |
| Recall Action Instructions |
Endocorp is advising their customer to quarantine the affected unit. A replacement ureterorenoscope will be provided. |
| Contact Information |
1800 816 003 - Endocorp Regulatory Affairs |