BEUDAMED
    FDA Recall Terminated

    Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065

    Recall: Z-1380-04 · Initiated July 30, 2004

    Recall

    Recall Number
    Z-1380-04
    Event Number
    29704
    Firm
    Bio-Detek, Inc.
    FEI Number
    1218058
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 30, 2004
    Posted
    August 18, 2004
    Terminated
    January 13, 2005
    Address
    525 Narragansett Park Dr, Pawtucket, RI, 02861-4323

    Description

    Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-2065

    Reason

    Pads may fail due to excessive corrosion of the electrode prior to the expiration date

    Action

    Biotek notified Zoll Medical Corp Zoll notified their customers by letter dated 7/28/04. Users are requested to discard electrodes and return an acknowledgement form. Recalled product will be replaced.

    Distribution

    Nationwide

    Quantity

    9.971 pairs