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Home / Uncategorized / FDA Safety Alert Announces Voluntary Recall of...

FDA Safety Alert Announces Voluntary Recall of Cabinet Mount Flowmeters

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The U.S. Food and Drug Administration (FDA) released a Safety Alert warning anesthesiologists and dentists of the voluntary recall of cabinet mount flowmeters manufactured by Accutron, Inc.  According to the alert, the flow meter may continue to release nitrous oxide gas after the oxygen has been turned off.

Though no injuries have been reported at this time, two customers have complained that the flowmeter continues to release nitrous oxide gas after the oxygen is shut off.  The inhalation of nitrous oxide when not mixed with oxygen can lead to brain damage and sometimes death, according to the FDA.

More than 200 flowmeters are affected by this recall.

The FDA recommends that healthcare professionals in possession of the affected flowmeters stop using them and return them to Accutron for a free replacement.

The recall, distributed by mail to distributors and customers, describes the process for returning and replacing the recalled product, according to the FDA.

The recalled flowmeters were distributed between November 26, 2008 and June 9, 2011.

For more details on the recall, including a list of model numbers associated with the recall, visit http://www.fda.gov/Safety/Recalls/ucm322808.htm.

If you believe you or a loved one has been harmed by a medical device, call Longo Legal, PLLC toll free at 855-566-4648.  We may be able to help.

View the full Safety Alert here.

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