FDA Issues Recall Alert on Nitrous Oxide Delivery System
The U.S. Food and Drug Administration (FDA) this week issued a "Class I" recall alert on Accutron, Inc.'s Ultra PC% cabinet mount flowmeters for nitrous oxide-oxygen sedation systems. The agency's safety alert and recall notice are available at the FDA web site.
According to the FDA, Accutron, which voluntarily recalled its flowmeters, reported two consumer complaints that the devices continued to deliver nitrous oxide even when the oxygen flow was turned off. No injuries have been reported.
The FDA's recall notice states: "Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
Dentists who suspect problems with this flowmeter should report them to Accutron at 1-800- 531-2221 and to the FDA via its MedWatch program. Accutron will replace the device free of charge.
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