Vapotherm, Inc. Vapotherm® 2000i and 2000h Respiratory Gas Humidifier
Class 1 Recall
|October 13, 2005|
|Product:||Vapotherm® 2000i and 2000h Respiratory Gas Humidifier|
|Use:||The Vapotherm 2000i and 2000h Respiratory Gas Administration delivers moisture to and warms breathing gases through a flexible nasal tube for patients receiving supplemental oxygen. The environments of use include home, hospital or sub-acute institutional settings.|
|Recalling Firm:||Vapotherm, Inc.
108 Log Canoe Circle
Stevensville, MD 21666
|Reason for Recall:||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 newborms could develop pneumonia, sepsis and in the most severe cases, death.|
Class I 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.
|For additional information, see the FDA’s 12/20/05 Preliminary Public Health Notification and the Vapotherm Press Release.|