REGULATORY UPDATE: 3M Issues Correction for Ranger Blood/Fluid Warming System

The Food and Drug Administration issued a medical device recall notice on Thursday to alert the blood and biotherapies community to a correction from 3M that clarifies instructions for use and labeling of the company’s Ranger blood/fluid warming system.

The recall affects high flow sets (catalog numbers 24355 and 24370) and irrigation fluid warming sets (catalog number 24750) manufactured after March 2022. The devices remain in use and on the market.

Testing revealed that the Ranger blood/fluid warming units cannot maintain the labeled output temperatures at the highest flow rates. For the Model 245 blood/fluid warmer, fluids at 4 degrees Celsius should not exceed 167 mL/min, and fluids at 20 degrees Celsius should not exceed 333 mL/min to ensure proper warming. The Model 247 irrigation warmer has updated specifications for flow rates up to 580 mL/min. Use outside these parameters could result in under-warmed fluids and may increase the risk of hypothermia or other serious adverse health consequences.

In an April 21 urgent medical device correction communication, 3M instructed users to continue using the devices with the updated guidance, notify all relevant staff, retain the notice until revised instructions are available and complete a customer acknowledgment form.

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