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Medical device recalled over concerns it could ignite and burst

The company has received two reports of incidents in which the device has malfunctioned, including one death.

The OxyTote by Western/Scott Fetzer is being recalled over the possibility that if it is mishandled, or dropped, the oxygen cylinder may ignite causing an internal flash fire and the canister to burst, according to the FDA.

The company 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 4 feet. Where the death occurred, the employee did not drop the gas cylinder, but set it down by his side, according to the FDA.

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 primary users of these devices are hospitals, nursing homes, and clinics.

Although the FDA website says the recall was initiated in January 2015, the agency sent out several emails about it on Tuesday, including a FDA MedWatch alert.

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