Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Finished Product Serial#. DS20070005 DS20090559 DS20100326 DS20100343 DS20100915 DS20101282 DS20070101 DS20080024 DS20080064 DS20080074 DS20080141 DS20080222 DS20080229 DS20080318 DS20090052 DS20090086 DS20090109 DS20090121 DS20090190 DS20090328 DS20090584 DS20090611 DS20090618 DS20090676 DS20090708 DS20090770 DS20090825 DS20090880 DS20090890 DS20090931 DS20090941 DS20100016 DS20100038 DS20100283 DS20100285 DS20100302 DS20100497 DS20100529 DS20100542 DS20100665 DS20100724 DS20100747 DS20100851 DS20100852 DS20100887 DS20100939 DS20101073 DS20101077 DS20101264 DS20101330 DS20101397 DS20101505 DS20110021 DS20110204 DS20110353 DS20110388 DS20110398 DS20110399 DS20110406 DS20110429 DS20110433 DS20110487 DS20110850 DS20110867 DS20110934 DS20110967 DS20111009 DS20111123 DS20111124 DS20111125 DS20111140 DS20111184 DS20111185 DS20111190 DS20111206 DS20120019 DS20120167 DS20120172 DS20120191 DS20120197 DS20100219 DS20100877 DS20110787 DS20110410 DS20080298 DS20100012 DS20100162 DS20100962 DS20100964 DS20110892 DS20110981 DS20070010 DS20070255 DS20080314 DS20090265 DS20090424 DS20090642 DS20090661 DS20090889 DS20100036 DS20100583 DS20101157 DS20101214 DS20101478 DS20111200 DS20120041 DS20070041 DS20090013 DS20090028 DS20090034 DS20090647 DS20090923 DS20100395 DS20100443 DS20101226 DS20101314 DS20101396 DS20101482 DS20101523 DS20111029 DS20111057 DS20111091 DS20111120 DS20120047 DS20120049
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- INO Therapeutics (dba Ikaria)
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Product Codes/Lot Numbers:
Finished Product Serial#. DS20070005 DS20090559 DS20100326 DS20100343 DS20100915 DS20101282 DS20070101 DS20080024 DS20080064 DS20080074 DS20080141 DS20080222 DS20080229 DS20080318 DS20090052 DS20090086 DS20090109 DS20090121 DS20090190 DS20090328 DS20090584 DS20090611 DS20090618 DS20090676 DS20090708 DS20090770 DS20090825 DS20090880 DS20090890 DS20090931 DS20090941 DS20100016 DS20100038 DS20100283 DS20100285 DS20100302 DS20100497 DS20100529 DS20100542 DS20100665 DS20100724 DS20100747 DS20100851 DS20100852 DS20100887 DS20100939 DS20101073 DS20101077 DS20101264 DS20101330 DS20101397 DS20101505 DS20110021 DS20110204 DS20110353 DS20110388 DS20110398 DS20110399 DS20110406 DS20110429 DS20110433 DS20110487 DS20110850 DS20110867 DS20110934 DS20110967 DS20111009 DS20111123 DS20111124 DS20111125 DS20111140 DS20111184 DS20111185 DS20111190 DS20111206 DS20120019 DS20120167 DS20120172 DS20120191 DS20120197 DS20100219 DS20100877 DS20110787 DS20110410 DS20080298 DS20100012 DS20100162 DS20100962 DS20100964 DS20110892 DS20110981 DS20070010 DS20070255 DS20080314 DS20090265 DS20090424 DS20090642 DS20090661 DS20090889 DS20100036 DS20100583 DS20101157 DS20101214 DS20101478 DS20111200 DS20120041 DS20070041 DS20090013 DS20090028 DS20090034 DS20090647 DS20090923 DS20100395 DS20100443 DS20101226 DS20101314 DS20101396 DS20101482 DS20101523 DS20111029 DS20111057 DS20111091 DS20111120 DS20120047 DS20120049
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1223-2015
Related Recalls
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.
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.
An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In addition, an unintended NO2 cell failure alarm may also occur. The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater tha