FDAnews
www.fdanews.com/articles/172258-scott-fetzer-subsidiary-recalls-valve-pressure-regulators

Scott Fetzer Subsidiary Recalls Valve Pressure Regulators

July 22, 2015

Scott Fetzer subsidiary Western has recalled its OxyTote, OxyQuik and AirTote line of valve integrated pressure regulators after receiving reports of three adverse ignition events, including one resulting in death.

Western determined the issue stemmed from a certain type of sealing O-ring that is more prone to igniting, according to a Jan. 31 letter alerting customers to the problem. The FDA designated the recall as Class 1 in a notice posted July 20, because of the risk of injury and death.

The products, which are mounted onto aluminum Oxygen cylinders, are used to dispense Oxygen at prescribed flow rates. Products mounted onto steel cylinders are not subject to the recall, the Westlake, Ohio, devicemaker says.

All affected lots were manufactured prior to October 2014. — Jason Scott