BEUDAMED
    FDA Enforcement Class II Terminated

    Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)

    Recall: Z-0369-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0369-2020
    Event ID
    83827
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carroll-Baccari, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 20, 2019
    Initiation Date
    September 5, 2019
    Classification Date
    November 13, 2019
    Termination Date
    October 19, 2021
    Address
    6625 White Dr, N/A, Riviera Beach, FL, 33407-1209, United States

    Description

    Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)

    Reason

    Product has the potential to be contaminated with Burholderia cepacia.

    Code Info

    MD0033T: 29769, 29915, 30067, 30643 MD0033-SUP: 29770,30027,30049, 30711

    Distribution

    US, Canada, Spain, England, and Australia

    Quantity

    2445 units