BEUDAMED
    FDA Enforcement Class II Terminated

    Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.

    Recall: Z-1969-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1969-2021
    Event ID
    87999
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spes Medica
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 7, 2021
    Initiation Date
    April 8, 2021
    Classification Date
    June 25, 2021
    Termination Date
    May 10, 2022
    Address
    Via Buccari 21, N/A, Genoa, N/A, N/A, Italy

    Description

    Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.

    Reason

    The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

    Code Info

    Lot LS20E2538I and 110320C

    Distribution

    Distribution in the following US states: CA, MA, and SC.

    Quantity

    8 boxes