BEUDAMED
    FDA Enforcement Class II Ongoing

    Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)

    Recall: Z-0409-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0409-2026
    Event ID
    97527
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vantive US Healthcare LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    November 5, 2025
    Initiation Date
    August 28, 2025
    Classification Date
    October 29, 2025
    Address
    1 Baxter Pkwy Bldg 6, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)

    Reason

    Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

    Code Info

    UDI-DI 15413765545723 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, Korea, New Zealand, Taiwan, Thailand, France, Germany, Ireland, Netherlands, Italy, Spain, Turkey, United Kingdom, Chile, and Colombia.

    Quantity

    1