BEUDAMED
    FDA Recall Terminated

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e 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. These MFE electrodes have a 12 month shelf life from time of manufacture.

    Recall: Z-2659-2014 · Initiated August 26, 2014

    Recall

    Recall Number
    Z-2659-2014
    Event Number
    69145
    Firm
    Bio-Detek, Inc.
    FEI Number
    1218058
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 26, 2014
    Posted
    September 17, 2014
    Terminated
    May 3, 2016
    Address
    525 Narragansett Park Dr, Pawtucket, RI, 02861-4323

    Description

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e 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. These MFE electrodes have a 12 month shelf life from time of manufacture.

    Reason

    Sterility of device is not assured

    Action

    BioDetek sent an Urgent Device Correction letter dated August 26, 2014, to all affected customers via UPS overnight delivery. There has also been notifications addressed to the 4 International accounts on August 27, 2014. Customers were requested to return the suspect product(s) in their possession and complete the Device Correction Response Return Form provided to each customer. Customer inventory will be replaced as soon as replacement electrodes are processed. Customers with questions can contact the technical support numbers at 1 (800) 348-9011 or +1 (978) 421-9460 24/7. For questions regarding this recall call 401-729-1400.

    Distribution

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

    Quantity

    12 each