| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00674-3 |
| Product Name/Description |
Alginot (dental impression material); All product lots within shelf life
AlgiNot Cartridge Intro Kit; Part No. 33034
AlgiNot Cartridge Refill; Part No. 33035
AlgiNot Sample Pack; Part No. 33141
AlgiNot FS Cartridge Intro Kit; Part No. 33816
AlgiNot FS Cartridge Refill; Part No. 33817
AlgiNot FS Sample Pack; Part No. 33848
AlgiNot Volume Refill; part No. 34680
AlgiNot Volume Intro Kit; Part No. 34681
AlgiNot FS Volume Refill; Part No. 34682
AlgiNot FS Volume Intro Kit; Part No. 34683 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
5/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
The current Instructions for Use (IFU's) for AlgiNot include product specifications and instructions that are not indicative of the actual performance of the product. More specifically, the IFU's incorrectly state the work time/mouth removal time. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Kerr Australia is providing updated Instructions for Use (IFU) |
| Contact Information |
1800 643 603 - Kerr Australia Customer Care |