FDA Issues Respiratory Device Recall

January 2006

The Food and Drug Administration (FDA) is warning health-care professionals about a respiratory device recall as a result of bacteria contamination.

The recalled respiratory devices, made by Vapotherm, are used to warm and moisten breathing gases such as oxygen. A few devices are used in homes, but most of the 5,000 devices recalled are used in hospitals. The FDA has received reports of the Vapotherm 2000i and 2000h Respiratory Gas Humidification systems being contaminated with Ralstonia and other bacteria. The bacteria could result in premature births and could cause patients with weakened immune systems to develop pneumonia or sepsis.

The FDA is looking into one death and three infections related to the contaminated respiratory devices.

For more information about recalled products, visit the Defective Products Legal Center.

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Source: “FDA Publicizes Recall of Respiratory Devices.” By Jennifer Corbett Dooren. The Wall Street Journal. January 31, 2006.