3M Announces Bair Hugger Recall for Design Defect, as First Forced Air Warmer Lawsuit Readies for Trial

Published on February 14, 2018 by Sandy Liebhard

The 3M Company is recalling thousands of Bair Hugger underbody blankets because of a design problem that could prevent the devices from warming patients during surgical procedures.

FDA Classifies Bair Hugger Recall Class II

The U.S. Food & Drug Administration (FDA) has categorized the Bair Hugger recall as a Class II medical device recall, which indicates that the affected blankets may cause temporary or reversible health problems.

The Bair Hugger forced air warming system is manufactured by 3M’s Arizant Healthcare subsidiary. The device is widely used by hospitals and surgical centers throughout the country to help patients maintain an optimal temperature during surgery. While the product line includes several types of disposable warming blankets, the recall only affects those placed under a patient to allow unimpeded access during procedures.

Because of a design change, the blankets included in the Bair Hugger recall are more susceptible to air blockages, which could result in partial airflow. Should that occur, the blanket would fail to fully inflate, impeding patient warming.

Notice of the Bair Hugger recall was posted on the FDA’s website on January 23rd.  The action includes more than 33,000 cases, each containing five units, with the following lot numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365 and R10366.

Healthcare providers have been advised to discard any Bair Hugger blankets affected by the recall.

First Bair Hugger Infection Lawsuit Heading to Trial

The Bair Hugger surgical warming system consists of a portable heater that is connected via flexible tubing to a disposable, inflatable blanket that is either placed over or under a patient during surgery. The heater is designed to draw in and warm ambient air, which is then forced through the tube and into the blanket.

3M and Arizant are currently named defendants in more than 4,200 Bair Hugger lawsuits, the majority of which were filed on behalf of hip and knee replacement patients who developed deep joint infections during their implant surgery. They claim that the Bair Hugger is to blame, and allege that it suffers from a design defect that allows potentially-contaminated air from the operating room floor to come into contact with the surgical site during procedures, greatly increasing the risk that patients undergoing orthopedic surgery will develop an infection at the site of their implant.

Federally-filed Bair Hugger lawsuits have been centralized in the U.S. District of Court, District of Minnesota.  The federal litigation will soon begin a series of bellwether trials, the first of which could be convened in April 2018. Verdicts in these test cases could provide some insight into how other juries might decide similar forced air warmer lawsuits.

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