See What’s Possible in Life Sciences Packaging @ PACK EXPO International
2,600 exhibitors. 150+ free educational sessions. See packaging solutions for life sciences & more @ PACK EXPO International, Oct 18-21 in Chicago
REGISTER NOW & SAVE

Create a free Healthcare Packaging account to continue reading

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.

See What’s Possible in Life Sciences Packaging at PACK EXPO International
Explore new machinery & materials from 2,600 exhibitors. Gain insights from 150+ free educational sessions. Find solutions to tackle the toughest challenges—for life sciences & beyond—at North America’s largest packaging & processing event.
REGISTER NOW & SAVE
See What’s Possible in Life Sciences Packaging at PACK EXPO International
Recyclable pill bottles are gaining pharmacy ground
Aluminum and paper-based prescription bottles are moving from concept to commercial reality. Here's what pharmacy and packaging leaders need to know.
Read More
Recyclable pill bottles are gaining pharmacy ground