Vapotherm Issues Urgent Recall of All Vapotherm 2000i Respiratory Gas Humidification Devices
Vapotherm, Inc. is stating in this press release that it is “initiating a nationwide recall of all Vapotherm 2000i Respiratory Gas Humidification devices. Some of these devices have been found to contain the Ralstonia species of bacteria. Ralstonia, as with any gram negative organism, may cause infection, sepsis and in most severe cases be life threatening. […] This device is used in both the home and in health care institutions for warming and humidifying breathing gases, such as oxygen, delivered by nasal cannula.
The firm first learned that patients were colonized by the bacteria from a Pennsylvania hospital on August 17, 2005, and subsequently issued a voluntary recall of the Vapotherm 2000i on October 13, 2005. FDA has since been apprised of this action.
At this time, the following information is known:
* There are numerous reports of Ralstonia colonization, including three reports of infection.
* One hospital, reported a death, but this has not been confirmed by Vapotherm
* 26 hospitals in 16 states have reported positive cultures of Ralstonia species from the Vapotherm 2000i device.”
All devices must be returned to the manufacturer for disinfection. Instructions for return are listed http://www.vtherm.com/recall or can be obtained by calling Vapotherm, Inc. at 1-866-827-6843
January 24, 2006 Related topics: Product Recalls, Quality, Safety, Errors