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U.S. Department of Health and Human Services

Safety

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Vapotherm 2000i and 2000h Respiratory Gas Humidifier

Audience: Neonatologists, respiratory healthcare professionals and hospital clinical managers

[Posted 01/30/2006] Vapotherm, Inc. and FDA notified healthcare professionals about the class 1 recall of the Vapotherm 2000i and 2000h products, which deliver moisture to and warm breathing gases through a flexible nasal tube for patients receiving supplemental oxygen in home, hospital or sub-acute institutional settings. FDA received reports of Vapotherm units becoming contaminated with Ralstonia spp and other bacteria. Exposure to these bacteria may cause patients to develop tracheitis, sepsis, pneumonia, or other serious infections. There is a reasonable probability that immunocompromised patients or premature newborms could develop pneumonia or sepsis. FDA recommends the use of alternative devices until the source of the contamination has been identified. Patients who have been exposed to the Vapotherm system should be monitored for signs and symptoms that may suggest infection and clinicians may want to consider Ralstonia infection in the differential diagnosis of symptomatic patients even if the organism has not been isolated.

[January 27, 2006 – Recall Notice – FDA]
[January 24, 2006 – Press Release –Vapotherm, Inc.]

Previous FDA/MedWatch alerts

[December 20, 2005]