Centurion Medical Products Corp. is recalling 80 airway kits and 70 components that contain Teleflex Inc.'s flexible tubes used for delivering oxygen to a patient's lungs.
The kits are used for opening a patient's airway, providing ventilation and administering anesthetic gas during a surgical procedure when a patient is under general anesthesia.
Centurion Medical, a Williamston, Mich.-based private healthcare equipment company, is recalling devices distributed between Nov. 28, 2018, and June 5. These devices were packaged together with Teleflex's tubes that are being recalled for a mechanical flaw that disconnects patients from the breathing circuit.
Patients disconnected from the breathing circuit risk low blood oxygen, decrease in vital signs and death. Wayne, Pa.-based Teleflex has received reports of four deaths and 18 injuries associated with disconnection, whereas Centurion Medical has not received any reports or complaints.
The U.S. Food and Drug Administration identified the June 7 recall as a class I, the most serious type of recall.