BEUDAMED
    FDA Enforcement Class I Terminated

    Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.

    Recall: Z-0044-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0044-2017
    Event ID
    75053
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    August 26, 2016
    Classification Date
    October 18, 2016
    Termination Date
    March 21, 2017
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.

    Reason

    The connector may disconnect from the tracheostomy tube during use.

    Code Info

    Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491

    Distribution

    Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.

    Quantity

    1095 units