Ikaria Inc. issued a Class I recall for the company’s Inomax DS nitric oxide delivery systems in the United States and Canada.
The potential failure of a pressure switch in the device may cause an interruption to the delivery of Inomax, or nitric oxide gas, for patients, the Clifton, N.J.-based company said.
A component within the pressure switch that monitors for when the gas supply should be replaced, according to the company, may tear.
Ikaria identified the potential problem during routing testing and did not report any injuries due to device failures. The company sent recall notices to its customers July 21 and has begun replacing the affected devices.
If a leak is suspected, Ikaria said clinicians should:
- Not interrupt the delivery of INOMAX.
- Verify an adequate amount of INOMAX remains in the cylinder.
- Switch to the manual back-up system using the INOblender by connecting the INOMAX Inlet Hose of the INOblender directly to the INOMAX regulator, and follow the standard procedure for use of the INOblender as the primary back-up method for manual ventilation.
- Contact Ikaria Customer Care at 877-566-9466 for assistance.
The company also recommends that pregnant women not be treated with unremediated Inomax DS systems.
