Recall Z-2483-2025

Reason for recall

Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.

FDA-determined cause: Device Design

Action taken

An Urgent Medical Device Correction letter was sent to all their customers on 4/21/2025 to inform them that Solventum [formerly 3M Company] clarified flow rates related to the inlet fluid temperature. The device instructions for use (IFU) will be updated to reflect these changes. Customers are informed that there have been no changes to the design or composition of these products that prompted this notification. Customers are instructed to continue to use the products as indicated, considering the updated information provided in the letter. 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. Under the dire circumstances of a massive rapid infusion where high flow rates outside of the updated ranges indicated below may be used, there is a potential for hypothermia. Customers with additional questions or need to report an adverse event, are instructed to contact the Solventum [formerly 3M Health Care] Customer Helpline at 1-800-228-3957, option 6.