Agency classClass IOur severity:Critical FDA (Devices)·Z-2069-2015·Announced 2015-07-29

Western OxyTOTE Portable Oxygen System Regulators Recalled for Ignition Risk

Western / Scott Fetzer Company is recalling OxyTOTE Portable Oxygen System regulators due to a risk of ignition and rupture of the oxygen cylinder.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that the hazard can cause 'serious injury and/or death,' which meets the rubric criteria for a Critical severity score (5) due to the potential for fatalities.

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…
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.

Lot numbers (20)

AAG-800
AAG-802
AAG-803
GTS-303
GTS-4206
GTS-600
GTS-603
JHR-900
JHR-LG-MTS-903
LAW-603
MNR-3000
MNR-600
MNR-800
MNS-602
MNS-603
MNS-803
MNS-C803
MTR-100
MTR-300
MTR-500

Distribution

Distributed in 47 states:

Same manufacturer · Western / Scott Fetzer Company

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Same hazard · explosion