| TGA Action ID |
RC-2025-RN-00415-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
3M Ranger Blood/Fluid Warming High Flow Set and 3M Ranger Fluid Warming Irrigation Set
Catalog Numbers: 24355, 24750
Lot numbers: all lot numbers manufactured after March 2022
ARTG's 219153, 219148 |
| ARTG Number |
219148, 219153 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Through an investigation by the product support team, it was determined the design requirements did not clearly specify the location of the temperature measurement and corresponding flow rate based on inlet temperature. As a result, it is recommended the design specifications and labelling be clarified for these items.
If the device is used at a flow rate outside of the updated information provided, there is a potential risk for the device to administer the fluids at a lower temperature than indicated and cause a decrease in patient temperature.
To date, there have been no hypothermia-related complaints reported associated with the use of the device. |
| Instructions for Customers/Users |
Customers may continue to use the products as indicated, taking into consideration the updated information provided below and in the customer letter.
Design requirements will be updated to specify the location of the temperature measurement and corresponding flow rate based on inlet temperature and associated documents:
• Hardware manual
• IFU documentation
• Design control matrix
· Keep the notice on hand until you are notified that the updated IFUs and operator’s manuals are available.
This action has been finalised on 16/3/2026. |
| Action Commencement Date |
1/05/2025 |
| Responsible Entity |
|
| Contact Information |
1300 524 822 or anzfieldaction@solventum.com |