BEUDAMED
    FDA Recall Terminated

    INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000

    Recall: Z-1410-06 · Initiated June 29, 2006

    Recall

    Recall Number
    Z-1410-06
    Event Number
    35892
    Firm
    INO Therapeutics, Inc.
    FEI Number
    3003323497
    Product Code
    MRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2006
    Posted
    August 25, 2006
    Terminated
    July 16, 2007
    Address
    6 State Route 173, Clinton, NJ, 08809-1269

    Description

    INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000

    Reason

    The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.

    Action

    On June 29, 2006, the firm sent a letter to its consignees advising them to visually verify that the Kel F tip is in place before attempting to connect either of the high pressure hoses to the INOmax cylinders. INO advised that if the tip was not in place, the operator should immediately replace the tip before attaching the hoses. On July 5, 2005, the firm sent a second letter to their consignees with extra Kel F tips and existing instructions from the INOvent Operation & Maintenance Manual outlining the proper replacement procedure for the tips. The firm is following with telephone contact to assure that the letters were delivered to the proper person(s).

    Distribution

    Worldwide, USA and countries of Canada, Uruguay, Chile, Argentina, Colombia, and Malaysia

    Quantity

    3,123 units