BEUDAMED
    FDA Enforcement Class II Terminated

    GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

    Recall: Z-2589-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2589-2014
    Event ID
    68939
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Galt Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    July 25, 2014
    Classification Date
    September 4, 2014
    Termination Date
    February 26, 2016
    Address
    2220 Merritt Dr, Garland, TX, 75041-6137, United States

    Description

    GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

    Reason

    The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.

    Code Info

    Catalot Numbers: KIT-043-06, KIT-043-07, KIT-043-08, KIT-043-09, KIT-043-10, KIT-043-11, KIT-053-06, KIT-053-07, KIT-053-08, KIT-053-09, KIT-053-10, KIT-053-11, KIT-053-12, KIT-053-17, KIT-053-18, KIT-053-19, KIT-053-20, KIT-053-21, and KIT-053-22

    Distribution

    Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.

    Quantity

    11,155 units in total