BEUDAMED
    FDA Recall 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 · Initiated August 30, 2012

    Recall

    Recall Number
    Z-2400-2012
    Event Number
    63098
    Firm
    Vascular Solutions, Inc.
    FEI Number
    3002827704
    Product Code
    DTL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 30, 2012
    Posted
    September 17, 2012
    Terminated
    December 4, 2012
    Address
    6464 Sycamore Ct N, Maple Grove, MN, 55369-6032

    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.

    Action

    The firm, Vascular Solutions, sent an "URGENT - Medical Device Field Safety Notice" dated August 24, 2012 and a follow-up "Urgent Medical Device Removal - Lot Specific" letter dated August 30, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check their inventory and to follow steps outlined in the letter which included to complete and return the "VSI Account Inventory Form" via email to: [email protected] or fax: to (763) 656-4251. If you have specific questions or concerns regarding this matter, please contact your local Vascular Solutions Account Manager; call (763) 656 4300 or email: Senior Regulatory Operations Associate at [email protected] and/or email: www.vascularsolutions.com.

    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