A Class II Medical Device Recall for 3M Bair Hugger System

A Class II Medical Device Recall for 3M Bair Hugger System

Introduction

While preparations are in full swing for the first bellwether trial for 3M Bair Hugger System lawsuits, scheduled to begin in April 2018, there comes a Class II Recall as categorized by the FDA for the forced air warming blankets belonging to the following lot numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, and R10366. The recall was made by the company after design defects were noticed which would prevent the affected blankets from warming patients during surgical procedures. More than 33,000 cases (each containing 5 units), sold worldwide are expected to be returned.

This recall does involve concerns about the airflow design but seems unrelated to the 3M infection cases which are consolidated in the District of Minnesota as MDL 2666- (In Re: Bair Hugger Forced Air Warming Devices Products Liability Litigation) before United States District Judge Joan N. Ericksen.

The court documents indicate more than 4,200 Bair Hugger lawsuits are pending which are filed on behalf of plaintiffs who developed serious and debilitating deep joint infections, allegedly related to the use of 3M’s forced-air warming blankets during their hip or knee replacement surgery.