Worldwide Recall; Portable Oxygen Unit May Ignite and Burst

The Western/Scott Fetzer Company of Westlake, OH, has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death. They received reports that when the valve integrated pressure regulator of the OxyTote portable oxygen unit is mishandled or dropped, the oxygen cylinder may ignite causing an internal flash fire and the canister to burst.


The firm has received a total of two reports of incidents in which the device has malfunctioned, including one injury and one death. When the injury occurred, the unit was dropped from four feet. Where the death occurred, the employee did not drop the gas cylinder, but set it down by his side.


Portable oxygen units provide oxygen to patients to help regulate their breathing while allowing them to travel around. Pressurized oxygen is stored in a special container and is delivered to the patient through tubing that is placed in the nostrils or through a mask. The pressure regulator is used to dispense oxygen at prescribed flow rates to patients for therapeutic purposes.


The primary users of these devices are hospitals, nursing homes, and clinics. The OxyTote units were manufactured and distributed between January 1, 2009, and September 30, 2014. Although distributed worldwide, the number of units distributed in the U.S. is 161,674.


See the Recall


See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe