BEUDAMED
    FDA Recall Terminated

    INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

    Recall: Z-0583-2012 · Initiated November 30, 2010

    Recall

    Recall Number
    Z-0583-2012
    Event Number
    60258
    Firm
    Ino Therapeutics
    FEI Number
    3004531588
    Product Code
    MRN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 30, 2010
    Posted
    January 11, 2012
    Terminated
    May 29, 2012
    Address
    2902 Dairy Dr, Madison, WI, 53718-3809

    Description

    INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

    Reason

    Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10.

    Action

    Ikaria sent a "RECALL- CUSTOMER PRODUCT REMEDIATION" notice dated December 22, 2011 to all affected customers. The letter describes the product, problem, actions taken by the firm. No action was required by customers. The notice served as correspondence to inform customers of the issue. Customers may direct their questions to Ikaria Customer Care at 1-877-566-9466.

    Distribution

    Worldwide Distribution-USA (nationwide) and the country of MALAYSIA.

    Quantity

    2446