BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1945-2019 · Initiated May 28, 2019

    Recall

    Recall Number
    Z-1945-2019
    Event Number
    83040
    Firm
    Bio-Detek, Inc.
    FEI Number
    1218058
    Product Code
    DTE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 28, 2019
    Terminated
    June 1, 2020
    Address
    525 Narragansett Park Dr, Pawtucket, RI, 02861-4323

    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.

    Action

    The firm notified customers of the recall on May 28, 2019, via Urgent Device Correction letter. Customers were advised to take the following actions: - Inform users of the problem. -Remove all stock of part numbers 8900-2105-01 and 8900-2106-01 with lot numbers 1719, 1719A , and 1819. - Complete the response form and return to ZOLL. A ZOLL representative will contact you to coordinate the return and replacement of your electrodes. Customers may direct their questions to the firm's 24/7 technical support numbers 1 (800) 348-9011 or +1(978)421-9460

    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