Blood and Plasma Warming Machine Correction: 3M Firm Points Correction for Ranger Blood/Fluid Warming System

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.    

Affected Product

Product Names: 3M Ranger Blood/Fluid Warming High Flow sets:

• 3M Ranger Blood/Fluid Warming High Flow Sets Catalog Numbers 24355 and 24370 used with 3M Ranger Blood/Fluid Warming Unit Model 245
• 3M Ranger Fluid Warming Irrigation Set Catalog Number 24750 used with 3M Ranger Irrigation Fluid Warming Unit Model 247

Table 1: 3M Ranger Blood/Fluid Warming Sets

Table 2: 3M Ranger Fluid Warming Irrigation Set

Continue to use the products as indicated, considering the updated information provided below:

• The 3M Ranger blood/fluid warming system uses Model 245 warming unit with high flow sets 24355 and 24370 to warm blood, blood products, and liquids from 4°C-20°C inlet temperatures to 33°C-41°C output temperatures. The system provides variable flow rates depending on inlet temperature: at 4°C inlet temperature, flow rates reach KVO to 167 mL/min, while at 20°C (ambient) inlet temperature, flow rates can reach KVO to 333 mL/min. The system features a 2-minute warm-up time to 41°C and includes temperature alerts at 43°C (over-temperature) and 33°C (under-temperature).
• The 3M Ranger irrigation fluid warming system uses Model 247 warming unit with set 24750 to warm irrigation fluids from 20°C inlet temperature to 33°C-41°C output temperatures. This gravity-fed system delivers flow rates up to 580 mL/min and features a 2-minute warm-up time to 41°C. The irrigation system includes temperature alerts at 48°C (over-temperature) and 33°C (under-temperature).  

On April 21, 3M Company sent all affected customers an Urgent Medical Device Correction – First Notice recommending the following actions:

• Ensure this notification is passed on to all those who need to be aware within your organization and to any department where the affected products have been transferred.
• Continue to use the products as indicated, considering the updated information provided.
• Keep this notice on hand until you are notified that the updated instructions for use (IFUs) and operator manuals are available.
• Complete the attached customer acknowledgement form.

Reason for Correction

3M Company is correcting the Ranger Blood/Fluid Warming System, a blood and plasma warming device, due to a needed labeling correction. The current label does not specify the location of the temperature measurement and corresponding flow rate based on inlet temperature.

The Ranger Blood/Fluid Warming System has a discrepancy between its labeled performance and actual capabilities. While the device is labeled to deliver fluids at 500 mL/min while maintaining 33°C-41°C output temperatures, testing revealed the heater cannot adequately warm fluid at high flow rates. The confirmed specifications show the device can only maintain proper warming temperatures at significantly lower flow rates: up to 333 mL/min with 20°C inlet fluid or up to 167 mL/min with 4°C inlet fluid. 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.

The use of affected product may cause serious adverse health consequences, including hypothermia and death.

There have been no reported injuries or deaths related to this issue.

Device Use

The Ranger Blood/Fluid Warming System is a medical device that warms blood, blood products, and liquids at flow rates from KVO to 500 mL/min, delivering fluids at temperatures between 33°C to 41°C depending on input conditions. The system consists of a Model 245 warming unit that mounts to an intravenous (IV) pole and sterile, single-use disposable warming sets available in pediatric, standard, and high flow configurations. The system must only be operated by trained medical professionals in clinical settings.  

Contact Information

Customers in the U.S. with questions about this recall should contact the 3M Customer Helpline at 1-800-228-3957, option 6.  

Additional FDA Resources:  

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I recognize a UDI on a label?  
AccessGUDID database – Identify Your Medical Device  
Benefits of a UDI System   

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.