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Oxygen Regulator Safety Alert



Do not replace factory installed dynamic seals on any Flotec Oxygen Regulators with any non-Flotec washers or seals.


When the factory installed Soft Seat Yoke Washer Seal is removed and replaced with a hard non-elastomeric washer, the FDA Class I medical device (MMD directive Class IIb) has been altered without the permission of Flotec.  This alteration is not endorsed under the FDA’s CGMP, ISO9001:2000, or ISO13485:2003.


In addition to the hazard of ignition of the seal, this modification of the regulator constitutes what the FDA describes as an “adulteration”.  This alteration exposes the buyer to liability should ignition occur.  The solution is “Do not replace Flotec factory-installed seals with any non-factory replacement parts.”

Many cylinder transfillers provide hard washers with each full cylinder.  When the new cylinder is put into service these hard washers are often used in place of Flotec’s Soft Seat Yoke Washer Seal.  Because these hard washers are not elastomeric it takes a great deal of extra torque on the T-Handle and the Dome Handle to achieve a proper high-pressure seal. The force required to effect a high-pressure seal with the hard washers is so great that many people use a wrench to force the T-Handle tight.  This over-torquing of the T-handle often damages the screw threads and bends the crossbar of the T-Handle.  There are numerous reports of ignition and burning of the hard washer seal when a proper high-pressure seal was NOT achieved.


The use of non-original equipment seals on Flotec yoke style (CGA 870) oxygen regulators are not approved by Flotec and Voids the Warranty.


SA-Yoke Washer Seal (draft).doc(10-14-03)