Reported Dec 17, 2014 · Terminated
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., 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) · 2902 Dairy Dr · Madison, WI · 53718-3809
Is this the product you have?
- INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.
- Lot codes and dates
- Serial Numbers
DS20080152DS20090925DS20101076DS20101499DS20110886DS20110965DS20120099DS20120150DS20120169
- Serial Numbers
- Amount recalled
- 9
Where it was sold
Why it was recalled
An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.
This product could cause temporary or reversible health problems — stop using it.
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