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: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES

    Recall: Z-1524-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1524-2024
    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: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES

    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) 7081015, UDI/DI00085412532554; b) 7081015ES, UDI/DI00085412532646; c) 7081520, UDI/DI00085412532561; d) 7081520ES, UDI/DI00085412532653; e) 7082025, UDI/DI00085412532578; f) 7082025ES, UDI/DI00085412532660; g) 7151015, UDI/DI00085412532585; h) 7151015ES, UDI/DI00085412532677; i) 7151520, UDI/DI00085412531908; j) 7151520ES, UDI/DI00085412531915; k) 7152025, UDI/DI00085412531922; l) 7152025ES, UDI/DI00085412531939; m) 7451015, UDI/DI00085412531946; n) 7451015ES, UDI/DI00085412531953; o) 7451520, UDI/DI00085412531960; p) 7451520ES, UDI/DI00085412531977; q) 7452025, UDI/DI00085412531984; r) 7452025ES, UDI/DI00085412531991

    Distribution

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

    Quantity

    82020 units