BEUDAMED
    FDA Enforcement Class II Terminated

    ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)

    Recall: Z-1945-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1945-2019
    Event ID
    83040
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-Detek, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2019
    Initiation Date
    May 28, 2019
    Classification Date
    July 3, 2019
    Termination Date
    June 1, 2020
    Address
    525 Narragansett Park Dr, N/A, Pawtucket, RI, 02861-4323, United States

    Description

    ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)

    Reason

    Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.

    Code Info

    Lots 1719, 1719A, and 1819

    Distribution

    Distributed to accounts in AZ, CA, CO, CT, FL, LA, MN, NV, OH, PA, TN, UT, and WY. International distribution to Canada, Germany, France, and Italy.

    Quantity

    1789