BEUDAMED
    FDA Enforcement Class I Terminated

    Avanos Cortrak 2 Enteral Access System (EAS)

    Recall: Z-1032-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1032-2022
    Event ID
    89997
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 25, 2022
    Initiation Date
    March 21, 2022
    Classification Date
    May 13, 2022
    Termination Date
    September 9, 2024
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    Avanos Cortrak 2 Enteral Access System (EAS)

    Reason

    Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.

    Code Info

    1) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS), UDI: 00350770472010; all serial numbers 2) Product Code P20-0950, CORTRAK 2 Enteral Access System (EAS) - Loaner Unit, UDI: 00350770472065; all serial numbers 3) Product Code 20-0950, CORTRAK 2 Enteral Access System (EAS) - Halyard version; UDI: 10680651472011; all serial numbers 4) Product Code P20-0950, CORTRAK 2 Enteral Access System (EAS) - Loaner Unit - Halyard version; UDI: 10680651472066; all serial numbers

    Distribution

    Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, and United Kingdom.

    Quantity

    721 devices