FDA Recall of Vapotherm Respiratory Humidifiers

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Class 1 Recall: Vapotherm, Inc. Vapotherm® 2000i and 2000h Respiratory Gas Humidifier

Date Recall Initiated: October 13, 2005 (Updated January 23, 2006, and January 26, 2006)

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.

Public Contact: David Lain, Chief Regulatory Officer, Vapotherm, Inc., 198 Log Canoe Circle
Stevensville, MD 21012, 410-604-3977

FDA District: Baltimore

FDA Comments:

FDA recommends the use of alternative devices until the source of the contamination has been identified.
In October 2005, Vapotherm issued new procedures for disinfecting the Vapotherm® 2000i and 2000h humidifiers, but these procedures have not been effective in eliminating Ralstonia spp. contamination in the devices.
Patients who have been exposed to the Vapotherm system should be monitored for signs and symptoms that may suggest infection, which may include, but are not limited to:
- changes in temperature;
- poor feeding, irritability; and
- changes in hematologic indices.
Clinicians may want to consider Ralstonia infection in the differential diagnosis of symptomatic patients even if the organism has not been isolated.

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.

http://www.fda.gov/cdrh/recalls/recall-101305.html

January 26, 2006, updated information:

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.

Vapotherm’s investigation is currently ongoing to identify the source of the Ralstonia contamination. In the meantime, Vapotherm’s plans include recalling and performing a disinfection process on the units.

http://www.fda.gov/oc/po/firmrecalls/ Vapotherm2000i_01_06.html

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