Oxygen Tank Regulator Recall Is Serious: Here's Why

Various OxyTOTE Portable Oxygen System regulators have been recalled over a potential danger of ignition and explosion.

Chris Newmarker

FDA has designated a Western/Scott Fetzer Co. recall of 162,678 various OxyTOTE portable oxygen system regulators as Class I.

The Class I designation, announced Monday, comes because Western/Scott Fetzer Co. (Westlake, OH) has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, with FDA listing component design or selection as the cause. Such an event could cause serious injury or death.

Affected devices were made before October 1, 2014. Lot and model numbers are available on FDA's website.

The company mailed an Urgent Medical Device Recall Notice notification to customers on January 31.

Western/Scott Fetzer Co. has touted the portable OxyTOTE's unique design, saying it promotes a safer environment for clinical staff and patients. The design was the result of extensive market research, focus groups, and feedback from potential health professional users, and a protective shroud provides durability, according to a company brochure.

The company notes that it has been making "All-in-One" units for more than a decade, and has 55 years experience designing and manufacturing high pressure and flow regulation products.

Read on to find out 10 of the worst medical device recalls so far this year.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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