Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers Recalled by INO Therapeutics (dba Ikaria) Due to Mallinckrodt discovered that some devices may have been...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact INO Therapeutics (dba Ikaria) directly.
Affected Products
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.
Quantity: 45
Why Was This Recalled?
Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device.
Where Was This Sold?
This product was distributed to 18 states: CA, CO, FL, GA, HI, IL, IN, IA, MI, MN, NJ, NM, NY, NC, OH, PA, TX, DC
About INO Therapeutics (dba Ikaria)
INO Therapeutics (dba Ikaria) has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report