Nitrous Oxide-Oxygen Flowmeters Recalled
Used for dental procedures, the devices have been recalled by Accutron, Inc. following two customer complaints that the device was flowing nitrous oxide gas without any oxygen gas flow.
Accutron, Inc. of Phoenix, Ariz., is alerting customers in anesthesiology and dentistry that it has voluntarily recalled the Ultra PC% Cabinet Mount Flowmeter, a product that controls the flow of gases used in nitrous oxide-oxygen sedation systems for dental procedures, after receiving two customer complaints that the device was flowing nitrous oxide gas without any oxygen gas flow. Inhaling nitrous oxide alone could lead to temporary and permanent brain damage and death, but the company's announcement said no injuries have been reported. The FDA posted a recall notice on Oct. 16.
A total of 206 devices are affected by this recall. They were manufactured from November 2009 to April 2009 and distributed from Nov. 26, 2008, to June 9, 2011. Consumers with the affected flowmeters should stop using them and return them to Accutron for a free replacement. The company notified distributors and customers of this recall by mail and is arranging for the return and replacement of all recalled products, according to the FDA.
This is a Class I recall, the most serious category, used for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death.