| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00173-1 |
| Product Name/Description |
Cure Sleeve (a dental barrier sleeve for curing light to prevent cross contamination)
Part Numbers: 4513C or 4513-1
Kit/Refill/Syringe Lot Numbers: 201403010110
ARTG Number: 161520 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Kerr Corporation received complaints that cases of Cure Sleeves labelled with part number 4513 contained inner boxes with part number 4500.
There is a low risk associated with the use of this product because the smaller sleeve size is unlikely to able to be applied to the larger tips. If the product is used; there would be a remote potential for cross contamination due to the tearing of the sleeve. |
| Recall Action |
Recall |
| Recall Action Instructions |
Kerr Corporation is contacting users to Recall affected units from the Market. This action has been closed-out on 15/07/2016. |
| Contact Information |
1800 643 603 - Kerr Australia Customer Care |