BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 26, 2024

    Recall

    Recall Number
    Z-0466-2025
    Event Number
    95483
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    3012307300
    Product Code
    MEA
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 26, 2024
    Posted
    November 15, 2024
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    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.

    Action

    Smiths Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 06/26/2024 via letter distributed by a traceable means. The notice explained the issue, potential risk, and requested the following: Locate all Model 21-0270-25 AC Adapters in your possession. Inspect the AC Adapter for damage to the input plug, missing AC prongs, or exposed metal contacts. If damaged, remove the AC Adapter from service and submit a request for credit to Smiths Medical at 800-258-5361. Distributors were directed to forward to the notice to those to whom the they distributed the device with the request to complete the response form and return it to [email protected].

    Distribution

    Worldwide distribution.

    Quantity

    156,400 AC adapters