BEUDAMED
    FDA Enforcement Class II Terminated

    Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

    Recall: Z-0783-2020 · Reported January 15, 2020

    Enforcement

    Recall Number
    Z-0783-2020
    Event ID
    84454
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    January 15, 2020
    Initiation Date
    December 9, 2019
    Classification Date
    January 7, 2020
    Termination Date
    December 14, 2020
    Address
    5050 Nathan Ln N, N/A, Plymouth, MN, 55442-3209, United States

    Description

    Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

    Reason

    Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.

    Code Info

    UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555

    Distribution

    Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay

    Quantity

    814 devices