BEUDAMED
    FDA Enforcement Class II Terminated

    PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)

    Recall: Z-1549-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1549-2020
    Event ID
    84587
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carroll-Baccari, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    April 1, 2020
    Initiation Date
    December 23, 2019
    Classification Date
    March 20, 2020
    Termination Date
    September 28, 2021
    Address
    6625 White Dr, N/A, Riviera Beach, FL, 33407-1209, United States

    Description

    PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)

    Reason

    Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.

    Code Info

    All Lots

    Distribution

    Nationwide, Canada, UK, Spain, Australia

    Quantity

    850 units