Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems Recalled because they might Flow Nitrous Oxide Gas without Oxygen Gas Flow

The FDA informs Risk Managers, Anesthesiology and Dentistry healthcare personnel that Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems are recalled because there is a potential of the flowmeter to continue releasing nitrous oxide gas when the oxygen is turned off. This can lead to permanent brain damage and death.

Background of Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems

Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems, by Accutron Inc., are used for controlling the flow of gases used in nitrous oxide-oxygen sedation systems. These systems are used for the sedation of patients during certain dental procedures. FDA Alert on Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems

FDA’s reason for the recall is that two complaints have been received concerning a defect of the Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems. The defect is that the flowmeter might continue releasing nitrous oxide gas when the oxygen is turned off leading to permanent brain damage and death.

The affected product manufacture dates are from November 2009 to April 2009 and distribution dates from November 26th, 2008, to June 9th, 2011.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems

“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.”

Contacting the FDA to report cases with Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems

In case of detection of adverse events or side effects related to the use of Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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