A Medical Device Daily
Vapotherm (Stevensville, Maryland) said it is initiating a nationwide recall of all Vapotherm 2000i Respiratory Gas Humidification devices used by healthcare facilities.
The company said some of its devices have been found to contain the Ralstonia species of bacteria. As with any gram-negative organism, Vapotherm said Ralstonia may cause infection, sepsis and in severe cases be life-threatening.
The device is used in both the home and in healthcare institutions for warming and humidifying breathing gases, such as oxygen, delivered by nasal cannula.
Vapotherm said there have been “numerous“ reports of Ralstonia colonization, including three reports of infection. It said 26 hospitals in 16 states have reported positive cultures of Ralstonia species from the Vapotherm 2000i device.
The company said one hospital had reported a death, but that it had not been confirmed by Vapotherm.
The company said its investigation to identify the source of the Ralstonia contamination is ongoing. In the meantime, Vapotherm's plans include recalling and performing a disinfection process on the units.
The company said healthcare facilities that have the Vapotherm 2000i device must return all units to Vapotherm and seek alternative respiratory gas humidification devices. It said instructions for return are listed on its recall information web site at http://www.vtherm.com/recall or by calling Vapotherm at (866) 827-6843.
The firm said it first learned from a Pennsylvania hospital on Aug. 17, 2005, that patients were colonized by the bacteria, and subsequently issued a voluntary recall of the Vapotherm 2000i on Oct. 13, 2005.
The Vapotherm devices were distributed through specialty distributors in the U.S. and internationally.