BEUDAMED
    FDA Recall Terminated

    CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)

    Recall: Z-0008-2008 · Initiated July 18, 2007

    Recall

    Recall Number
    Z-0008-2008
    Event Number
    38894
    Firm
    Lemaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 18, 2007
    Posted
    October 4, 2007
    Terminated
    September 8, 2008
    Address
    63 Second Avenue, Burlington, MA, 01803-4413

    Description

    CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)

    Reason

    Sterility of device may be compromised due to breach in sterile barrier.

    Action

    The firm issued a "Adivsory Notice" to accounts 7/18/07, advising them to examine inventory and remove product with defective packaging. The firm issued an updated notification dated 9/24/07 advising users to return recalled lots instead of conducting an examination of the product at the user site.

    Distribution

    Worldwide, including USA, Canada, Netherlands, and Germany.

    Quantity

    7,860 units