BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0783-2020 · Initiated December 9, 2019

    Recall

    Recall Number
    Z-0783-2020
    Event Number
    84454
    Firm
    Abbott Medical
    FEI Number
    3005334138
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    December 9, 2019
    Terminated
    December 14, 2020
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    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.

    Action

    Beginning on 12/09/2019, consignees were notified in person by an Abbott field representative. The firm is seeking return of the affected units. For questions about this issue or for replenishment contact your local Abbott Representative or Abbott Support at 1-855-478-5833 (option 1).

    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