BEUDAMED
    FDA Enforcement Class I Terminated

    Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.

    Recall: Z-0004-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0004-2017
    Event ID
    75181
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leonhard Lang Medizintechnik GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    September 1, 2016
    Classification Date
    October 14, 2016
    Termination Date
    March 26, 2019
    Address
    Archenweg 56, N/A, Innsbruck, N/A, N/A, Austria

    Description

    Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.

    Reason

    There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.

    Code Info

    US: 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 50130-0777; 41023-0771; 41008-0778; 40730-0778; 40618-0778; and, 40130-0776. Outside US: 60725-0774; 60620-0776; 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 40827-0777; 40730-0778; 40618-0778; and, 40130-0776.

    Distribution

    Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon, and Poland.

    Quantity

    11,110 ( US 8,040; OUS 3,070)