Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall - Flowmeter May Continue To Release Nitrous Oxide Gas When The Oxygen Is Turned Off
MedSun: Newsletter #78, November 2012

FDA MedWatch Safety Alert

Accutron voluntarily recalled the product after learning through two customer complaints that the flowmeter was flowing nitrous oxide gas without any oxygen gas flow. When not mixed with oxygen, inhaling nitrous oxide can lead to temporary and permanent brain damage and death. Consumers with the affected flowmeters should stop using and return the flowmeters to Accutron for a free replacement. The company notified distributors and customers of this recall by mail and is arranging for return and replacement of all recalled products.

Additional Information:

Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall - Flowmeter May Continue To Release Nitrous Oxide Gas When The Oxygen Is Turned Off. FDA MedWatch Safety Alert. October 16, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm324120.htm


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