BEUDAMED
    FDA Enforcement Class II Terminated

    APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.

    Recall: Z-0719-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0719-2021
    Event ID
    86803
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    November 23, 2020
    Classification Date
    December 23, 2020
    Termination Date
    March 14, 2023
    Address
    1601 Wallace Dr Ste 150, N/A, Carrollton, TX, 75006-6690, United States

    Description

    APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.

    Reason

    There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.

    Code Info

    All APEX Compounding System with Software Version 1.0.5.57 or earlier

    Distribution

    US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN,TX, WA.

    Quantity

    16 units