The Ultra PC% Cabinet Mount Flowmeter has been recalled by the Food and Drug Administration (FDA) on October 16, 2012 with a Class 1 recall. A Class 1 recall is the most concerning category for products that present a “situation in which there is a reasonable probability that the use of these products will cause serious adverse health consequences or death” according to the FDA.
This flowmeter is manufactured by Accutron, Inc. in Phoenix, Arizona. In early October, the company alerted customers in dentistry and anesthesiology that it was voluntarily recalling this specific product that was manufactured from November 2009 through April 2009 and was distributed until June 9, 2011. This particular equipment is used in nitrous oxide-oxygen sedation for dental patients. The FDA report states “Some of the flowmeters have been found to release Nitrous Oxide gas when the Oxygen is turned off. A flowmeter releasing Nitrous Oxide gas without Oxygen could potentially lead to serious injuries like brain damage in patients.” Accutron was first alerted to this mishap when two patients complained that the device seemed to be releasing nitrous oxide only and no oxygen.
This recall affects 206 pieces of equipment. Dental offices and anesthesiologist with this device should immediately stop using it. All consumers and distributors have been notified by mail of this recall. Accutron is replacing these products free of charge and has arranged for the return of the faulty product. If you need an Oklahoma City product liability or defective product attorney, contact Johnson & Biscone.