BEUDAMED
    FDA Recall Open, Classified

    BD Pyxis Pro MedStation Main, REF: 1155-00

    Recall: Z-0370-2026 · Initiated September 30, 2025

    Recall

    Recall Number
    Z-0370-2026
    Event Number
    97566
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    BRY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 30, 2025
    Posted
    October 27, 2025
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    BD Pyxis Pro MedStation Main, REF: 1155-00

    Reason

    Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

    Action

    On September 30, 2025, BD issue a Urgent Medical Device Recall Expansion notification to affected consignees via FedEx. BD is asking consignees to take the following actions: 1. Affected products can continue to be used per existing Manuals and Guides. 2. In the event of an accidental fluid spill on the device or in a drawer, users should following instructions outlined within the customer notification. 3. Review the customer letter attachment which provides warnings, cautions and recommendations regarding fluid ingress. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

    Quantity

    27 units