BEUDAMED
    FDA Enforcement Class II Ongoing

    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbers: a) FT12100, b) FT12125, c) FT12150, d) FT12175, e) FT12200, f) FT12225, g) FT12250, h) FT12275, i) FT12300,

    Recall: Z-1523-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1523-2024
    Event ID
    94119
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2024
    Initiation Date
    February 22, 2024
    Classification Date
    April 12, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbers: a) FT12100, b) FT12125, c) FT12150, d) FT12175, e) FT12200, f) FT12225, g) FT12250, h) FT12275, i) FT12300,

    Reason

    The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).

    Code Info

    Cardiovascular Specialty marketing brochures: Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version; Flo-Thru Intraluminal Shunt: ALL SERIAL NUMBERS: a) FT12100, UDI/DI 00085412532004, b) FT12125, UDI/DI 00085412532011, c) FT12150, UDI/DI 00085412532042, d) FT12175, UDI/DI 00085412532059, e) FT12200, UDI/DI 00085412532066, f) FT12225, UDI/DI 00085412532073, g) FT12250, UDI/DI 00085412532080, h) FT12275, UDI/DI 00085412532097, i) FT12300, UDI/DI 00085412532103

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.

    Quantity

    112760 units