Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-01586-1 |
Product Name/Description |
Algerbrush II and Algerbrush II Accessories
Algerbrush – II Rust Ring 0.5mm instrument and Rust Ring 1.0mm instrument
Algerbrush – II Accessories 0.5mm Burr/Chuck and 1.0mm Burr/Chuck
ARTG Number: 93755 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
12/12/2016 |
Responsible Entity |
|
Reason/Issue |
The operating instructions for sterilisation (version 2) were either missing or obsolete. The new operating instructions (version 3) contain specific time and temperature for sterilisation. Failure to follow the new Operating Instructions may result in potential adverse events, including eye infections. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
iNova Pharmaceuticals is advising health practitioners to replace their Algerbrush-II Operating Instructions (v2) with the new instructions provided (v3) and to ensure that all relevant staff is informed of this change to the operating instructions. This action has been closed-out on 27/06/2017. |
Contact Information |
1800 251 150 - iNova Pharmaceuticals Customer Service |