FDAJanuary 31, 2015device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

western scott fetzerwesternwestern scott

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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