Western OxyTOTE Portable Oxygen System Regulators Recalled for Ignition Risk

Plain-English summary

Western / Scott Fetzer Company is recalling various OxyTOTE Portable Oxygen System regulators, specifically the Valve Integrated Pressure Regulator. The recall affects 162,678 units distributed worldwide, including the United States, Canada, and several other countries. The affected units are used to dispense oxygen at prescribed flow rates to patients for therapeutic purposes.

The recall is being conducted because the firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder. This hazard can cause serious injury and/or death. The recall includes all lot numbers made prior to October 1, 2014, for specific model numbers such as AAG-403, AAG-800, and MTR-100.

Consumers should stop using the affected regulators immediately. The source text does not provide specific instructions on how to return the product or contact the manufacturer, but users should verify if their specific model and lot number are included in the recall list.

The recalled product

Product

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

Manufacturer

Western / Scott Fetzer Company

Category

Medical Device — Oxygen Therapy Equipment

Hazard

• explosion
• fire
• serious-injury

Affected units

162,678

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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