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Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System
The FDA is aware that on April 21, 3M Company sent all affected customers an Urgent Medical Device Correction for the Ranger Blood/Fluid Warming System. 3M Company is correcting the labeling for the Ranger Blood/Fluid Warming System as the current label does not specify the location of the temperature measurement and corresponding flow rate based on inlet temperature. If the device is used at a flow rate outside of the updated information, there is a potential risk for the device to administer the fluids at a lower temperature.
There have been no reported injuries or deaths related to this issue.
This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Questions?
Customers in the U.S. with questions about this recall should contact the 3M Customer Helpline at 1-800-228-3957, option 6.
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