BEUDAMED
    FDA Recall Open, Classified

    BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

    Recall: Z-1304-2025 · Initiated February 18, 2025

    Recall

    Recall Number
    Z-1304-2025
    Event Number
    96323
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    PHC
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 18, 2025
    Posted
    March 13, 2025
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

    Reason

    Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

    Action

    On February 18, 2025, Becton, Dickinson issued a " Urgent Medical Device Product Correction" Notification. to affected consignees via Fed-Ex and E-Mail. 1. Users should review all infusion parameters pre-populated and confirm they are correct before pressing START as stated in the BD Alaris User Manual. 2. Disseminate this notice within your facility network to ensure that all concerned personnel are made aware of this issue. 3. BD Project Managers will engage with you to address any questions regarding this notice, and specific next steps for your facility. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form, regardless of whether you have any of the impacted material. This will allow BD to confirm receipt of this notification. 5. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program.

    Distribution

    US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None