| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00786-1 |
| Product Name/Description |
Zenostar MT Color and Zenostar MT Color Impulse products
Multiple product numbers and lot numbers affected. |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has become aware that the primary packaging of the product may show leaks. As a consequence, the liquid may leak from the dropper of the bottle.
Direct contact with certain substances contained in this liquid may lead to serious eye damage and/or skin irritation. If contact is made with skin, rinse with water and if irritation continues, seek medical assistance.
This action was undertaken prior to consultation with the Therapeutic Goods Administration (TGA). |
| Recall Action |
Recall |
| Recall Action Instructions |
Ivoclar Vivadent is advising users to inspect stock and return. |
| Contact Information |
03 9707 9627 - Ivoclar Vivadent |