BEUDAMED
    FDA Recall Terminated

    VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths. The device is indicated for use in sealing the femoral arterial puncture site.

    Recall: Z-0762-04 · Initiated July 28, 2003

    Recall

    Recall Number
    Z-0762-04
    Event Number
    28389
    Firm
    Datascope Collagen Products Division
    FEI Number
    3003071194
    Product Code
    MGB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2003
    Posted
    July 20, 2004
    Terminated
    April 6, 2004
    Address
    1300 MacArthur Blvd., Mahwah, NJ, 07430-0605

    Description

    VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths. The device is indicated for use in sealing the femoral arterial puncture site.

    Reason

    Kits are missing the temporary arteriotomy locator (TAL) from the blister package.

    Action

    'Urgent Customer Advisory' Letter dated July 28, 2003.

    Distribution

    The device was distributed throughout the US to 101 direct accounts. There was one distributor. There was one government account.

    Quantity

    1485 kits