BEUDAMED
    FDA Enforcement Class II Terminated

    CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.

    Recall: Z-1277-2018 · Reported April 11, 2018

    Enforcement

    Recall Number
    Z-1277-2018
    Event ID
    79479
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Halyard Health, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 11, 2018
    Initiation Date
    December 13, 2017
    Classification Date
    March 30, 2018
    Termination Date
    November 4, 2021
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.

    Reason

    The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube. Based on specifications, the transmitting stylet in the NG tube should not be visible within the port window.

    Code Info

    Product code 20-9551TRAK2A, Lot No. 7909, 7839, 7876.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AR, CA, CO, GA, IA, LA, MI, MN, NM, TX; and country of Germany. Distributed internationally to Germany.

    Quantity

    185 cases (10 units per case)