BEUDAMED
    FDA Enforcement Class II Terminated

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    Recall: Z-2660-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2660-2014
    Event ID
    69145
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-Detek, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2014
    Initiation Date
    August 26, 2014
    Classification Date
    September 17, 2014
    Termination Date
    May 3, 2016
    Address
    525 Narragansett Park Dr, N/A, Pawtucket, RI, 02861-4323, United States

    Description

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    Reason

    Sterility of device is not assured

    Code Info

    Lot Number: 2314

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.

    Quantity

    100 cases =600 units