BEUDAMED
    FDA Enforcement Class II Terminated

    Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE

    Recall: Z-2101-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-2101-2019
    Event ID
    83240
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 7, 2019
    Initiation Date
    June 14, 2019
    Classification Date
    July 30, 2019
    Termination Date
    June 11, 2020
    Address
    125 Blue Ball Rd, N/A, Elkton, MD, 21921-5315, United States

    Description

    Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE

    Reason

    Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

    Code Info

    Lot Number: WP17

    Distribution

    MI Foreign: Japan, Belgium

    Quantity

    16 units