The valves might stick and prevent or reduce the flow of oxygen, a risk that defines the recall as a Class I type because of the risk of serious injury or death. There is no data yet on how many complaints have been reported to the company or regulatory agencies.
13K ventilator parts pulled in Class I recall
Madison, Wis.-based Mallinckrodt Manufacturing recalled about 13,600 one-way valves made for ventilators, according to FDA data.
