| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00840-1 |
| Product Name/Description |
CA1:1L EVO 15 (Contrangle used in dentistry)
Part Number: 1600939-001
Serial Numbers: 15F0030, 15F0040, 15F0036
ARTG Number: 141205 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
There is the possibility of loosening of the dental tool, which may lead to potential safety risk if swallowed by the patient. The tool is not well held in the chuck system of the device.
This action has been undertaken prior to consultation with the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
William Green is replacing all affected devices with unaffected product. This action has been closed-out on 11/04/2016. |
| Contact Information |
1300 363 830 - William Green Pty Ltd |