BEUDAMED
    FDA Recall Terminated

    Ivenix Infusion System (IIS)

    Recall: Z-1381-2022 · Initiated April 22, 2022

    Recall

    Recall Number
    Z-1381-2022
    Event Number
    90314
    Firm
    Ivenix, Inc.
    FEI Number
    3014732157
    Product Code
    PHC
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 22, 2022
    Terminated
    May 20, 2024
    Address
    50 High St, Ste 50, North Andover, MA, 01845-2620

    Description

    Ivenix Infusion System (IIS)

    Reason

    Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.

    Action

    On April 22, 2022, the firm notified affected customers of the product issue through a letter titled "Important Safety Update." The firm is working on a software update to correct the issue. It will be available in approximately 60 days. The firm will inform customers when the update is ready to install. As interim corrections, the firm recommends that any pump that is infusing into the downstream access port have an infusion pressure less than 525 mm Hg. Alternatively, the Occlusion Retry Attempts in the Infusate Library Care Profile Pump Setting should be set to 0. Care profile pump settings are described in the Infusate Library and Pump Management Instructions for Use. If you have additional questions, please contact Customer Support: [email protected] or 1-978-775-8100

    Distribution

    US Nationwide distribution in the states of NJ and WI.

    Quantity

    1335 devices