Reported Feb 1, 2017 · Terminated
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for…
INO Therapeutics (dba Ikaria)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INO Therapeutics (dba Ikaria) · 6603 Femrite Dr · Madison, WI · 53718-6801
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers
DS20070030DS20070043DS20070094DS20070268DS20090096DS20090458DS20090484DS20090539DS20090620DS20090645DS20100071DS20100118DS20100216DS20100266DS20100268DS20100330DS20100439DS20100496DS20100604DS20100675DS20100744DS20100762DS20100950DS20101199DS20101337DS20101359DS20101369DS20101406DS20101443DS20101524DS20110242DS20110480DS20110577DS20110849DS20110868DS20110912DS20110915DS20110972DS20110976DS20110990DS20120008DS20120161DS20120266DS20120281DS20120370
- Serial Numbers
- Amount recalled
- 45
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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