Reported Mar 11, 2015 · Terminated
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
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) · 2902 Dairy Dr · Madison, WI · 53718-3809
Is this the product you have?
- Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
- Lot codes and dates
- Finished Product Serial#.
125 of 125 codes
DS20070005DS20090559DS20100326DS20100343DS20100915DS20101282DS20070101DS20080024DS20080064DS20080074DS20080141DS20080222DS20080229DS20080318DS20090052DS20090086DS20090109DS20090121DS20090190DS20090328DS20090584DS20090611DS20090618DS20090676DS20090708DS20090770DS20090825DS20090880DS20090890DS20090931DS20090941DS20100016DS20100038DS20100283DS20100285DS20100302DS20100497DS20100529DS20100542DS20100665DS20100724DS20100747DS20100851DS20100852DS20100887DS20100939DS20101073DS20101077DS20101264DS20101330DS20101397DS20101505DS20110021DS20110204DS20110353DS20110388DS20110398DS20110399DS20110406DS20110429
- Finished Product Serial#.
- Amount recalled
- 45 units
Where it was sold
Why it was recalled
Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.
This product could cause temporary or reversible health problems — stop using it.
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