The FDA has issued a Public Health Notification urging users to exercise caution when using the reintroduced Vapotherm 2000i respiratory Gas Humidifier System.
Vapotherm Inc recalled the device in 2005 due to possible contamination with Ralstonia spp. cultures and the FDA has noted that premature neonates, immunocompromised patients, and those with underlying respiratory illness such as cystic fibrosis or malignancy, may be at particularly high risk for infection if exposed to breathing gases from a contaminated Vapotherm device. As part of the recall, the company has been disinfecting the units for users.
The company has been working with the CDC and FDA in implementing corrective actions to minimize the risk to patients. The FDA continues to monitor the reintroduced device and encourages users to report any further problems.
Reports can be submitted to MedWatch, the FDA’s voluntary reporting program, by calling (800) FDA-1088 or visiting the Web site.