BEUDAMED
    FDA Enforcement Class II Terminated

    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    Recall: Z-0052-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0052-2015
    Event ID
    69409
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-Detek, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2014
    Initiation Date
    September 16, 2014
    Classification Date
    October 8, 2014
    Termination Date
    May 3, 2016
    Address
    525 Narragansett Park Dr, Pawtucket, RI, 02861-4323, United States

    Description

    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    Reason

    Product sterility is not assured

    Code Info

    Lot Numbers: 1614, 1814, 1914

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.

    Quantity

    237 cases (6/case)