3M Company recalls 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2483-2025
• FDA 510(k) clearance · K973741The device's official FDA premarket clearance record
• FDA device classification · BSBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.9205The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find 3M CompanySearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.