BEUDAMED
    FDA Recall Terminated

    Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene Oxide, Possis Medical, Inc., 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003. (These sets are used with the new AngioJet Ultra Console)

    Recall: Z-1131-2007 · Initiated June 19, 2007

    Recall

    Recall Number
    Z-1131-2007
    Event Number
    38244
    Firm
    Possis Medical, Inc
    FEI Number
    2183460
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 19, 2007
    Posted
    August 10, 2007
    Terminated
    March 2, 2008
    Address
    9055 Evergreen Blvd Nw, Minneapolis, MN, 55433-5833

    Description

    Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene Oxide, Possis Medical, Inc., 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003. (These sets are used with the new AngioJet Ultra Console)

    Reason

    Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary vessels. These units should indicated use only for peripheral arteries.

    Action

    A Urgent Medical Device recall letter dated 19 June 2007, was sent to consignees advising that all unused product be removed and returned to Possis. An acknowledgement of the disposiiton of the product will be requested from consignees.

    Distribution

    AR, AZ, CA, FL, GA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI, WV

    Quantity

    194