BEUDAMED
    FDA Enforcement Class II Completed

    Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.

    Recall: Z-1019-2022 · Reported May 11, 2022

    Enforcement

    Recall Number
    Z-1019-2022
    Event ID
    89897
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2022
    Initiation Date
    April 1, 2022
    Classification Date
    April 29, 2022
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.

    Reason

    There is a potential for foreign matter.

    Code Info

    Product Code: FT12150; Lot: SP21J21-1584173

    Distribution

    Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom

    Quantity

    300 devices