Portable Oxygen Tank Explosion Risk Leads to Recall of OxyTOTE Units

More than 160,000 portable oxygen units are subject to a Class I medical device recall, following reports of explosions that have caused at least one fatality and one injury. 

An OxyTOTE pressurized portable oxygen unit recall was announced by the FDA on August 18, following two reports of problems where the oxygen cylinder ignited, causing an internal flash fire and for the canister to burst.

Portable oxygen tanks are used to provide oxygen to patients with respiratory issues, to help regulate their breathing while allowing them to be mobile.

The pressurized oxygen in the tank is delivered to the patient through connecting breathing tubes that are placed in the nostrils or through a mask. These forms of oxygen tanks are typically used in hospitals, nursing homes, and clinics, but are also used at the consumer level and for in-home and portable use.

Explosions are a potential risk with portable oxygen tanks if they are mishandled or dropped, posing a risk of serious and potentially life-threatening injury. Upon a certain degree of impact, the oxygen cylinder can ignite, causing an internal flash fire and causing the aluminum tank to burst. Owners and bystanders can be at risk of serious injury and death from the force of the explosion and shrapnel from the bursting canisters.

However, the reported injury linked to the OxyTOTE oxygen unit occurred when a tank was accidentally dropped from just four feet, causing the tank to ignite and explode. The fatality resulted from an oxygen tank being set down directly next to an employee’s side with presumably too much force, causing an explosion.

The recall includes an estimated 161,674 OxyTOTE portable oxygen units manufactured and distributed from January 1, 2009 to September 30, 2014. The units were manufactured by Western/Scott Fetzer Company of Westlake, Ohio where they were distributed for sale, consignment, and rental to various distributors, hospitals, healthcare facilities, health care service providers, EMS staff, ambulance providers, and oxygen tank fillers and service providers. For a full list of recalled portable oxygen canisters, please visit the recall website linked above.

Western/Scott Fetzer Company began informing customers of the potential oxygen tank explosion issues on January 31, 2015 via mailing notice and is instructing customers to locate and identify whether any tanks in their inventory are included in the recall and to contact their OxyTOTE/oxyQuik/AirTOTE supplier or Medical Gas Provider directly to schedule a remediation. Customers with further questions should either contact Western/Scott Fetzer Company at 800-783-7890 or visit them online at http://westernenterprises.com/recall/.

Class I recalls are the most dangerous recalls put out by the FDA and involve situations where there is a reasonable probability that the use of a particular product will cause serious adverse health consequences or death.