BEUDAMED
    FDA Recall Terminated

    Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.

    Recall: Z-1223-2015 · Initiated January 14, 2015

    Recall

    Recall Number
    Z-1223-2015
    Event Number
    70395
    Firm
    INO Therapeutics (dba Ikaria)
    FEI Number
    3004531588
    Product Code
    MRN
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    January 14, 2015
    Posted
    February 27, 2015
    Terminated
    April 15, 2015
    Address
    2902 Dairy Dr, Madison, WI, 53718-3809

    Description

    Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.

    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.

    Distribution

    Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV.

    Quantity

    45 units