BEUDAMED
    FDA Enforcement Class I Terminated

    Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

    Recall: Z-0969-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-0969-2017
    Event ID
    75875
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    BARD PERIPHERAL VASCULAR, INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    December 2, 2016
    Classification Date
    January 18, 2017
    Termination Date
    April 5, 2017
    Address
    1415 W 3rd St, Tempe, AZ, 85281-7634, United States

    Description

    Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

    Reason

    Complaints of sheath separation, kinking, and/or tip damage during use.

    Code Info

    Product Code Lot Number UDI Number Quantity HAL590 50137570 (01)00801741111525(17)170331(10)50137570 95 HAL590 50137770 (01)00801741111525(17)170331(10)50137770 79 HAL590 50137979 (01)00801741111525(17)170331(10)50137979 95 HAL590 50138696 (01)00801741111525(17)170430(10)50138696 23

    Distribution

    Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.

    Quantity

    101