3M Co. has recalled 33,000 cases of their Bair Hugger blankets due to a design defect that may prevent the underbody blankets from warming patients during surgery.
The recall is a Class 2 recall and classified as medium-severity by the FDA. The company’s recall notice said that health care providers should identify and discard any blankets affected by the recall.
The following lot numbers have been recalled: R10362, R10359, R10361, R10360R10363, R10365, R10364 and R10366. A total of 33,108 cases have been recalled, each containing five units. The cases were distributed worldwide.
According to the FDA, forced-air surgical blankets, like the ones being recalled by 3M, are designed to maintain the patient’s body temperature during surgery to prevent infection and promote healing.
3M’s Bair Hugger line of products has many types of inflatable blankets, but the recall only affects “underbody” models. These blankets lie underneath the patient to give the surgeon unimpeded access to the body during surgery.
According to the FDA’s alert, 3M recalled the blankets because a design change makes some blankets more susceptible to airflow blockage. If the blanket is only partly inflated during the surgery, the patient may not receive complete warming therapy.
The Bair Hugger invention was purchased by 3M in 2010 and has been used on more than 200 million patients across the world. More than 80% of hospitals in the U.S. have the system installed.
Thousands of plaintiffs have claimed that the blankets caused deep-joint infections after orthopedic surgery. They claim the system blows around bacteria that may come to rest in the surgical wound. 3M denies these allegations, and says the device has been proven safe in real-world experiments.
More than 4,000 lawsuits are pending over Bair Hugger blankets, and more than half of the plaintiffs developed deep joint infections after hip and knee replacement surgery.
The allegations in the lawsuit are in no way connected to the recall.