BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1549-2020 · Initiated December 23, 2019

    Recall

    Recall Number
    Z-1549-2020
    Event Number
    84587
    Firm
    Carroll-Baccari, Inc.
    FEI Number
    3017189082
    Product Code
    KOY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 23, 2019
    Terminated
    September 28, 2021
    Address
    6625 White Dr, Riviera Beach, FL, 33407-1209

    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.

    Action

    The firm initiated the recall by issuing a public notice on 12/24/2019 then followed with recall letters on 12/26/2019. The firm followed with an amended recall notice disseminated on 01/07/2020, which removed the Collodion products, removers, and acetone. The letters requested the following actions: "1. Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it. 2. Fill out the Medical Device Recall form below and email it to [email protected] 3. We will follow up and give instructions on how to return the product for credit." Contact Mavidon at 800-654-0385 or by email to [email protected]

    Distribution

    Nationwide, Canada, UK, Spain, Australia

    Quantity

    850 units