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FDA identifies CareFusion’s ventilator recall as Class I

Posted on June 2, 2015 10:27 am under Product Liability

The U.S. Food and Drug Administration has identified CareFusion’s recall of certain units of AVEA ventilator as Class I, which means using the product could pose serious or life-threatening hazards to individuals using it, the agency reported on May 27.

The company first recalled its ventilators on April 21 after learning that the defective units may exhibit a persistent Extended High Peak or Circuit Occlusion alarm. This would then open the safety valve, causing the unit to stop ventilating. In case of a malfunction, the company has advised healthcare providers to remove the ventilator from the service and provide an alternate unit to prevent health complications.

Poorly-designed medical equipment like this could significantly endanger a patient’s life. At Habush Habush & Rottier S.C. ®, we help Milwaukee residents harmed by a defective medical device hold the manufacturer responsible for any injuries or costs sustained. Call us at (414) 271-0900 today for a free assessment of your case.