The FDA has issued a Class 1 Recall Vapotherm® 2000i and 2000h Respiratory Gas Humidifiers. “Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.”
According to the agency: “FDA has received reports of Vapotherm units becoming contaminated with Ralstonia spp, and other bacteria. Exposure to these bacteria may cause patients to develop tracheitis (infection of the trachea), sepsis (infection in the bloodstream), pneumonia (lung infection), or other serious infections. There is a reasonable probability that immunocompromised patients or premature newborns could develop pneumonia, sepsis and in the most severe cases, death.”
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