7625 West New York Street

Indianapolis, Indiana 46214-4911 USA

Telephone: (317) 273-6960

Facsimile: (317) 273-6979

Order Desk Telephone: (800) 401-1723

Order Desk Facsimile: (800) 515-9254

Oxygen Regulator Safety Alert / Yoke Washer
Technical Bulletin 

There have been numerous instances of ignition of plastic yoke washer seals used to replace factory installed dynamic seals on Oxygen Regulators. When the factory installed Soft Seat Yoke Washer Seal is removed and replaced with a hard plastic washer, the Class I medical device has been altered without the permission of the manufacturer.  This alteration is extremely dangerous and is not endorsed under CGMP.

In addition to the hazard of ignition of the plastic 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 factory-installed seals with plastic yoke washer seals."

Many cylinder transfillers provide hard plastic washers with each full cylinder.  When the new cylinder is put into service these hard plastic washers are often used in place of the manufacturer's Soft Seat Yoke Washer Seal.  Because these hard plastic 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 plastic 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 plastic yoke washer seal when a proper high-pressure seal was NOT achieved. 

The use of plastic seals on yoke style (CGA 870) oxygen regulators is dangerous to your patients, operators, and your financial health.