BEUDAMED
    FDA Recall Terminated

    Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.

    Recall: Z-1657-2009 · Initiated May 6, 2009

    Recall

    Recall Number
    Z-1657-2009
    Event Number
    52077
    Firm
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation
    FEI Number
    2024168
    Product Code
    MGB
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 6, 2009
    Posted
    July 6, 2009
    Terminated
    December 21, 2011
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.

    Reason

    Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.

    Action

    Between May 6 and May 8, 2009, Sales Representatives visited accounts to recover the product. Recall notifications (Urgent Product Recall letters, dated May 6, 2009) were hand delivered to customers advising them Abbott Vascular is voluntarily recalling one lot of the StarClose Vascular Closure System for a potential stenlity issue discovered internally. Customers are asked to cease use of devices from this lot and work with their local account representative to review their inventory. complete the attached Recall Effectiveness Check Form and rerturn Identified products to Abbott Vascular.

    Distribution

    Nationwide distribution.

    Quantity

    240 units