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U.S. Department of Health and Human Services

Safety

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Vapotherm 2000i (Respiratory Gas Humidifier System)

Audience: Neonatologists, respiratory healthcare professionals, hospital clinical managers

[Posted 02/01/2007] FDA notified healthcare professionals of the reintroduction of the 2000i Respiratory Gas Humidifier System. This system was recalled in 2005 due to possible contamination with Ralstonia spp. cultures. FDA noted that premature neonates, immunocompromised patients and those with underlying respiratory illness (such as cystic fibrosis) or malignancy may be at particularly high risk for infection if exposed to breathing gases from a contaminated Vapotherm device. FDA issued recommendations for the steps to take before using the reintroduced device.

[February 01, 2007 – Public Health Notification – FDA]

Previous MedWatch alert

[December 20, 2005]

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