BEUDAMED
    FDA Enforcement Class II Ongoing

    smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

    Recall: Z-0466-2025 · Reported November 27, 2024

    Enforcement

    Recall Number
    Z-0466-2025
    Event ID
    95483
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2024
    Initiation Date
    June 26, 2024
    Classification Date
    November 15, 2024
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

    Reason

    The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.

    Code Info

    Model 21-0270-25, UDI/DI 15019517126844, All lots

    Distribution

    Worldwide distribution.

    Quantity

    156,400 AC adapters