BEUDAMED
    FDA Enforcement Class II Terminated

    Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.

    Recall: Z-2243-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2243-2016
    Event ID
    74547
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Parker Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 27, 2016
    Initiation Date
    June 2, 2016
    Classification Date
    July 19, 2016
    Termination Date
    January 31, 2017
    Address
    5085 Weeping Willow Cir, N/A, Highlands Ranch, CO, 80130-4485, United States

    Description

    Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.

    Reason

    Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.

    Code Info

    Model Number: H-PFTVPU-60; H-PFTVPU-65; H-PFTVPU-70; H-PFTVPU-75; H-PFTVPU-80; H-PFTVPU-85; H-PFTVPU-90; H-PFTVVC-60; H-PFTVVC-65; H-PFTVVC-70; H-PFTVVC-75; H-PFTVVC-80; H-PFTVVC-85; H-PFTVVC-90 Lot Numbers: 1512TVC2029I through 1512TVC2029O (I, J, K, L, M, N, O); 1602TVC0226I through 1602TVC2226O (I, J, K, L, M, N, O); 1602TVU0226I through 1602TVU0226O (I, J, K, L, M, N,O); 1512TVU2029I through 1512TVU2029O (I, J, K, L, M, N,O)

    Distribution

    US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.

    Quantity

    5,500 units