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.