FDA announces Class 1 recall for pediatric resuscitator

Editor's Note

The US Food and Drug Administration (FDA) has deemed Mercury Medical’s recall of Neo-Tee Resuscitators a Class 1, the most severe category indicating serious risk of injury or death.

According to the agency’s October 7 announcement, the recall was motivated by potential for the inline controller to come apart, resulting in loss of positive pressure and potentially, ischemia and death.

Intended to provide emergency breathing support to neonates and infants weighing less than 22 lbs, the gas-powerd resuscitator has not been associated with any reported injuries or deaths, FDA reports. Users are instructed to quarantine affected products and contact Mercury Medical customer service.