Accutron Nitrous Oxide System Recall Due to Brain Damage Risk
A recall has been issued on flowmeters, which distribute nitrous oxide-oxygen used for sedation, after at least two cases were reported where the flowmeters released nitrous oxide gas when the oxygen was turned off, posing a risk of brain damage and potentially life threatening injuries for consumers.
The FDA decided this week that a Ultra PC% Cabinet Mount Flowmeter recall letter sent out last spring by Accutron, Inc. constituted a Class I medical device recall, which suggests that continued use of the product may cause serious injury or death.
Accutron warned customers to stop using the flowmeters immediately, due to the risk of inhaling nitrous oxide when the oxygen is turned off, which can cause temporary and permanent brain damage.
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To date, no injuries have been reported, but at least two consumer indicated that when the oxygen was turned off the machine continued to release nitrous oxide.
The recall affects 8 different models of the Ultra PC% Cabinet Mount Flowmeter, totaling 206 flowmeters that were manufactured from November 2009 to April 2009 and distributed from November 26, 2008 to June 9, 2011. The model numbers of the recalled products are 50000, 36800-NS, 36800, 36700, 36600-NS, 36600, 31970, and 27025.
Nitrous oxide leaks are extremely dangerous, because at room temperature the gas has a faint sweet odor that is colorless and non-flammable and can go unrecognized for lengths of time. Exposure to high concentrations can produce many different serious health problems such as edema, bronchiolitis obliterans, chronic lung disease, and death
The FDA recommends that consumers who have the affected flowmeters stop using them immediately and return the affected products to Accutron for a free replacement. Accutron says it has already notified distributors and customers by mail and is making arrangements to accept the devices back and to replace them.
Health care professionals and consumers should stop using this product immediately and report any problems they experience to the FDA’s MedWatch adverse event reporting program.
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