BEUDAMED
    FDA Recall Terminated

    Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033

    Recall: Z-2565-2014 · Initiated March 12, 2013

    Recall

    Recall Number
    Z-2565-2014
    Event Number
    68970
    Firm
    Bio-Detek, Inc.
    FEI Number
    1218058
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 12, 2013
    Posted
    September 2, 2014
    Terminated
    June 17, 2015
    Address
    525 Narragansett Park Dr, Pawtucket, RI, 02861-4323

    Description

    Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033

    Reason

    Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators

    Action

    Bio-Detek issued an Urgent Field Safety Notice to Medsolutions4 U on 3/12/13, informing them of the problem and actions that should be taken to remove the affected products from service.

    Distribution

    Worldwide Distribution in Germany and Slovenia.

    Quantity

    30 cases (300 electordes)