BEUDAMED
    FDA Recall 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 · Initiated December 16, 2016

    Recall

    Recall Number
    Z-1399-2017
    Event Number
    76299
    Firm
    Parker Medical
    FEI Number
    3002986772
    Product Code
    CBI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2016
    Posted
    March 3, 2017
    Terminated
    April 17, 2017
    Address
    5085 Weeping Willow Cir, Highlands Ranch, CO, 80130-4485

    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.

    Action

    Parker Medical notified consignees via telephone on December 16, 2016. Consignees were instructed to segregate affected products for immediate pick up. For questions regarding this recall call 239-307-6064.

    Distribution

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

    Quantity

    1,060 units