BEUDAMED
    FDA Enforcement Class II Terminated

    Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.

    Recall: Z-1478-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1478-2018
    Event ID
    79624
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 2, 2018
    Initiation Date
    January 19, 2018
    Classification Date
    April 20, 2018
    Termination Date
    July 18, 2018
    Address
    6200 Jackson Rd, N/A, Ann Arbor, MI, 48103-9586, United States

    Description

    Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.

    Reason

    Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).

    Code Info

    Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.

    Distribution

    Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.

    Quantity

    7