BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01

    Recall: Z-1579-2023 · Reported May 17, 2023

    Enforcement

    Recall Number
    Z-1579-2023
    Event ID
    92061
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2023
    Initiation Date
    April 5, 2023
    Classification Date
    May 11, 2023
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01

    Reason

    Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload processing error. Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.

    Code Info

    REF/UDI-DI/Software: 323/10885403512667/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 352/10885403512674/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 327/10885403477836/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 1116-00/10885403512605/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 107-255-01/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4

    Distribution

    US Nationwide distribution in the states of KS, NY, NC, LA, MA, MI.

    Quantity

    1,474