Events

Recall of Device Recall INOmax DSIR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by INO Therapeutics (dba Ikaria).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70395
  • Event Risk Class
    Class 2
  • Event Number
    Z-1223-2015
  • Event Initiated Date
    2015-01-14
  • Event Date Posted
    2015-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133448
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Apparatus, nitric oxide delivery - Product Code MRN
  • Reason
    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.
  • Action
    Consignees were sent on 1/14/2015 an Ikaria "Urgent Field Correction Action" letter dated January 14, 2015. The letter described the problem and the product involved in the recall. The letter provided a number of recommendations to the consginees in regard to use and return of the product. For questions or adverse events they can contact Ikaria Customer Care at 1-877-KNOW-INO (1-877-566-9466) 24 hours a day, 7 days a week.

Device

Device Recall INOmax DSIR
  • Model / Serial
    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
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV.
  • Product Description
    Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
  • Manufacturer
    INO Therapeutics (dba Ikaria)

Manufacturer

INO Therapeutics (dba Ikaria)
  • Manufacturer Address
    INO Therapeutics (dba Ikaria), 2902 Dairy Dr, Madison WI 53718-3809
  • Manufacturer Parent Company (2017)
    Mallinckrodt Plc
  • Source
    USFDA