BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.

    Recall: Z-1207-2023 · Reported March 29, 2023

    Enforcement

    Recall Number
    Z-1207-2023
    Event ID
    91341
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2023
    Initiation Date
    February 14, 2023
    Classification Date
    March 17, 2023
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.

    Reason

    Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications.

    Code Info

    REF/UDI-DI: 327/10885403477836, 323/10885403512667, 352/10885403512674

    Distribution

    Worldwide - US Nationwide distribution including in the states of NY, PA, OH, TX, FL, KY, IL, DE, AK, WI, KS, LA, WA, AZ, CO, MI, IN, TN, SD, AR, MO, CA, NV, MA, SC, VA, WV, CT, ME, NE, RI, GA, NC, IA, MN, AL, OK, MS, NM, NH, VT, WY, OR, ID, NJ, UT, DC, HI, MD, MT, ND and the country of Canada.

    Quantity

    7914