| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00156-1 |
| Product Name/Description |
Helioseal Clear, 1.25g syringes
Batch Number: U30755
ARTG Number: 98805 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ivoclar Vivadent is removing Helioseal Clear from circulation as a precautionary measure. It cannot be guarrenteed that the material of the affected lot can be sufficiently cured with all polymerization lights. There is no risk to patient health as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Ivoclar is advising users to stop using the affected product and return.
This action has been closed-out on 14/11/2016. |
| Contact Information |
03 9707 9627 - Ivoclar Vivadent |