Medical Device Safety and Recalls: Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit May Ignite and Burst

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit May Ignite and Burst

A recall has been issued for Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit.

The company received reports that when the OxyTote 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 2 reports of incidents in which the device has malfunctioned, including 1 injury and 1 death. When the injury occurred, the unit was dropped from 4 feet; where the death occurred, the employee did not drop the gas cylinder, but set it down by his side.

For more information, please see:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm458740.htm.

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