| Subject: | FDA Issues Guidance for Using the Reintroduced Vapotherm 2000i [Respiratory Gas Humidifier] System |
| Category: | Food and Drug Administration (FDA)
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| Published: | Mon, 5 Feb 2007 - 12:00 am |
| Vapotherm, Inc. has reintroduced the 2000i [Respiratory Gas Humidifier] System. This system was recalled in 2005 due to possible contamination with Ralstonia spp. cultures. In October 2005, the 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. Please see the StayAlert notice dated... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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