BEUDAMED
    FDA Recall Terminated

    ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.

    Recall: Z-2334-2008 · Initiated June 16, 2008

    Recall

    Recall Number
    Z-2334-2008
    Event Number
    48753
    Firm
    Bio-Detek, Inc.
    FEI Number
    1218058
    Product Code
    MLN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 16, 2008
    Posted
    September 20, 2008
    Terminated
    May 10, 2016
    Address
    525 Narragansett Park Dr, Pawtucket, RI, 02861-4323

    Description

    ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.

    Reason

    Multi-function electrode programmed as a Pediatric instead of Adult

    Action

    Bio-Deteck notified the own label distributor and in cooperation the firm notified their customers by letter dated 6/16/08. Users are requested to return the lots and replacement product will be provided. Zoll issued and Urgent Device Correction letter on June 16, 2008 with instructions to follow if the device is used with the defective electrodes. If you have questions, contact ZOLL Medical Technical Service at 1-800-348-9011.

    Distribution

    MA

    Quantity

    25 cases of 8/cs for each lot # ; Total of 400 units