INO Therapeutics (dba Ikaria): Medical Device Recalls in 2017

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by INO Therapeutics (dba Ikaria) in 2017. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

2014

2015

2017

Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and 02 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.