| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00233-1 |
| Product Name/Description |
Safe-T-Vue 6 and Safe-T-Vue10 Temperature Indicators (used to monitor the temperature of blood bags during transit)
Multiple part numbers and lot numbers affected
ARTG Number: 265484 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Temptime is making a change to Safe-T-Vue’s instructions for use. The instructions on the box and package insert state that indicators must be removed from refrigeration and brought to room temperature every 3 months. Temptime conducted additional testing and determined that Safe-T-Vue indicators must be removed from refrigeration for 24 to 48 hours every 2 months. Storing Safe-T-Vue in refrigerated conditions for greater than 2 months may lead to failure of the indicator to change colour when the specified temperature has been reached. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Helena Laboratories is providing updated Instructions For Use (IFU) for users to follow. |
| Contact Information |
(03) 9543 7299 - Helena Laboratories Australia Pty Ltd |