BEUDAMED
    FDA Recall 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 · Initiated June 2, 2016

    Recall

    Recall Number
    Z-2243-2016
    Event Number
    74547
    Firm
    Parker Medical
    FEI Number
    3002986772
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 2, 2016
    Posted
    July 19, 2016
    Terminated
    January 31, 2017
    Address
    5085 Weeping Willow Cir, Highlands Ranch, CO, 80130-4485

    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.

    Action

    Customers were notified on June 2, 2016 that a recall was initiated via telephone. The information communicated identified the affected product, problem and actions to be taken. Customers were instructed to segregate the affected product for immediate pick-up. A Sales Representatives went to each hospital and retrieved all unused product.

    Distribution

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

    Quantity

    5,500 units