Accutron, Inc. is recalling some of its gas tanks used to deliver nitrous oxide-oxygen to sedate patients during dental procedures because of two customer reports that the flowmeter on the tank was flowing nitrous oxide without any oxygen gas flow. When not mixed with oxygen, inhaling nitrous oxide can lead to temporary and permanent brain damage and death. There have been no injury reports to date.
Accutron issued the recall on eight models of the Ultra PC% Cabinet Mount Flowmeter, which includes 206 units. The gas tanks were manufactured from November 2009 to April 2009 and distributed from November 26, 2008 to June 9, 2011.
Dental offices and other customers with the recalled flowmeters should stop using them immediately and return them to Accutron for a free replacement.
The Food and Drug Administration (FDA) listed the recall as a Class 1, which is the most serious type of recall the FDA can order and involves situations in which there is a reasonable probability that use of the products will cause serious adverse health consequences or death.
Consumers with questions may call Accutron at 1-800-531-2221. Any adverse reactions or quality problems experienced using these devices should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Photo credit: GUANTANAMO BAY, Cuba – Navy Cmdr. George Sellock, a dentist deployed with Joint Task Force Guantanamo’s Joint Troop Clinic, performs dental work on a Trooper’s tooth, May 13, 2009. The JTC is a first line aid station for JTF Guantanamo Troopers. (JTF Guantanamo photo by Army Spc. Cody Black)