BEUDAMED
    FDA Recall Terminated

    GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

    Recall: Z-2588-2014 · Initiated July 25, 2014

    Recall

    Recall Number
    Z-2588-2014
    Event Number
    68939
    Firm
    Galt Medical Corporation
    FEI Number
    3000718472
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 25, 2014
    Posted
    September 4, 2014
    Terminated
    February 26, 2016
    Address
    2220 Merritt Dr, Garland, TX, 75041-6137

    Description

    GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 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.

    Action

    Galt Medical sent an Urgent Medical Device Recall letters to all affected customers. The letter identified the affected product, reason for recall and actions to be taken. Customers were asked to identify and segregate the recalled lot (s) that is in their possession, complete and return the enclosed Recall Reply form, and return the recalled product to Galt Medical Corp. For questions contact your local sales representative or Recall Coordinator at 214-778-1306.

    Distribution

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

    Quantity

    11,155 units in total