BEUDAMED
    FDA Enforcement Class II Terminated

    Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries

    Recall: Z-1399-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1399-2017
    Event ID
    76299
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Parker Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 15, 2017
    Initiation Date
    December 16, 2016
    Classification Date
    March 3, 2017
    Termination Date
    April 17, 2017
    Address
    5085 Weeping Willow Cir, N/A, Highlands Ranch, CO, 80130-4485, United States

    Description

    Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries

    Reason

    The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.

    Code Info

    Lot Numbers: 1605DL0814A, 1605DL0814B, 1601LD2001C, 1605DL0814C, 1601DL2001D, 1605DL0814D, 1601DL2001E, 1605DL0814E, 1605DL0814F

    Distribution

    Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee.

    Quantity

    1,060 units