BEUDAMED
    FDA Recall 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 · Initiated September 5, 2019

    Recall

    Recall Number
    Z-0369-2020
    Event Number
    83827
    Firm
    Carroll-Baccari, Inc.
    FEI Number
    3017189082
    Product Code
    KOY
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 5, 2019
    Terminated
    October 19, 2021
    Address
    6625 White Dr, Riviera Beach, FL, 33407-1209

    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.

    Action

    The firm initiated the recall of Lemon Prep by email on 09/05/2019. Distributors were directed to notify their customers and ask them to contact Mavidon directly. Direct accounts were asked to cease use and contact the company for replacement. The firm issued a press release on 09/30/2019 and posted a copy along with a copy of the recall notice on their website. The firm initiated the recall of its Pedia Prep on 10/08/2019 by email and posted a copy of the recall letter on its website.

    Distribution

    US, Canada, Spain, England, and Australia

    Quantity

    2445 units