Flowmeters for Nitrous Oxide-Oxygen Sedation Systems recalled nationwide due to potential flaw
The U.S. Food and Drug Administration has issued a safety alert to advise dentists, anesthesiologists and other consumers of a nationwide voluntary recall of flowmeters manufactured by Accutron Inc. due to a potential flaw, although no injuries have been reported to date.
Accutron, a Phoenix-based manufacturer of conscious sedation equipment, voluntarily issued the recall of 206 flowmeters sold as Ultra PC% Cabinet Mount Flowmeters.
Dentists may contact Accutron at 1-800-531-2221 with questions.
The device is under a Class I recall, deemed so because there is a reasonable probability of serious adverse health consequences or death associated with the defective units.
No injuries have been reported to date, but the recall was prompted by two customer complaints that the flowmeters continued to release nitrous oxide gas after the oxygen is turned off. According to the FDA, "When not mixed with oxygen, inhaling nitrous oxide can lead to temporary and permanent brain damage and death."
Health care professionals who own the affected flowmeters should stop using them and return them to Accutron for free replacement, the FDA said on its website.
“The company notified distributors and customers of this recall by mail and is arranging for return and replacement of all recalled products,” according to the FDA. “Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.”
Call the FDA at 1-800-332-1088 to request a reporting form, or complete and submit a form at www.fda.gov/MedWatch/report.htm.
The recalled flowmeters were distributed between November 26, 2008 and June 9, 2011. For a list of model and serial numbers associated with the recalled flowmeters, visit www.fda.gov/Safety/Recalls/ucm322808.htm.