Western / Scott Fetzer Company recalls Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product U…

Recall date

January 31, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2069-2015

FDA classification

Class I

Brand / firm

Western / Scott Fetzer Company

Sold / distributed

Worldwide Distribution -- US, including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Ca…

Why it was recalled

The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.