BEUDAMED
    FDA Enforcement Class II Terminated

    Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.

    Recall: Z-2400-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2400-2012
    Event ID
    63098
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascular Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    August 30, 2012
    Classification Date
    September 17, 2012
    Termination Date
    December 4, 2012
    Address
    6464 Sycamore Ct N, Maple Grove, MN, 55369-6032, United States

    Description

    Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.

    Reason

    Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.

    Code Info

    lots 27686, 27293, 22446

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, CT, DE, FL, GA, ID, IL IN , KY, LA,MD, MN, MO, NV, NM, NY, OH, PA, SC, TN, TX, VA, WA, and WV; and countries of: Italy and Korea. Italy, Korea

    Quantity

    3500 units