BEUDAMED
    FDA Enforcement Class II 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 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2565-2014
    Event ID
    68970
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-Detek, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 10, 2014
    Initiation Date
    March 12, 2013
    Classification Date
    September 2, 2014
    Termination Date
    June 17, 2015
    Address
    525 Narragansett Park Dr, Pawtucket, RI, 02861-4323, United States

    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

    Code Info

    Lot #0413 Expiration Date: 2015-01-26

    Distribution

    Worldwide Distribution in Germany and Slovenia.

    Quantity

    30 cases (300 electordes)