Response to FDA Safety Advisory


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Indianapolis, Indiana 46214-4911 USA
Telephone: (317) 273-6960
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Order Desk Telephone: (800) 401-1723
Order Desk Facsimile: (800) 515-9254
E-mail: info@floteco2.com
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By now you have learned that the FDA and NIOSH have published a Public Health Advisory on Explosions and Fires in Aluminum Oxygen Regulators. We have talked directly to the FDA and have determined from them that there are no restrictions on selling or using existing Flotec regulators nor is there any need or plan to recall any product. The Flotec FIRE Resistant, Unibody Regulator is in production and available from stock right now. In its 15 year history of making regulators there has never been an event or report of ignition within a Flotec regulator. Our assessment of its safety has not changed. The Flotec regulator is safe for use as an EMS, Hospital or Home Care oxygen regulator. Do not hesitate to continue using or selling any Flotec regulator.

Flotec does produce a regulator with all BRASS yoke bodies with anodized aluminum flowmeter assemblies for those who want the extreme additional safety offered by the all BRASS construction. The entire high-pressure zone is BRASS and the low-pressure flowmeter is anodized aluminum. The "FDA has no reports of fire or explosion with aluminum oxygen regulators used in low pressure (<50 psi)" therefore the use of aluminum on the flowmeter is not an area of concern. Be sure to order the "T" option for this special feature.

The Flotec Aluminum Unibody Regulator incorporates a unique high-pressure inlet design that is made entirely of BRASS. This patent pending design has an all BRASS high pressure construction which can be considered incapable of burning. The internal relief valve, shown below in purple, opens almost instantly if internal pressures exceed 95 PSI thus preventing pressure spikes that can occur during the opening of the cylinder tank. The piston, shown below in green and the manifold are separate components assuring complete independent function of the relief valve.

The high-pressure flow path of oxygen in the Flotec regulator first flows though the BRASS retainer, shown below in pink, that retains both the BRONZE inlet filter and the BRASS insert, shown below blue. The inlet filter, shown below in yellow, is constructed of Sintered Bronze and has a nominal filter rating of 10 micron. The filter is not flexible and will not collapse, as screen type filter are prone to do. The BRASS retainer and the BRONZE inlet filter and the BRASS insert can easily be removed for cleaning, conversion or replacement.

The result is that Flotec’s FIRE Resistant; Unibody Regulator is the safest, most durable versatile design available.

For more information on the BRASS lined Flotec Regulators, the safest regulator on the market, call (317) 273-6960. Flotec can provide fast delivery of regulators within 48 hours or less.