BEUDAMED
    FDA Recall Terminated

    AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 USA.

    Recall: Z-0469-06 · Initiated December 12, 2005

    Recall

    Recall Number
    Z-0469-06
    Event Number
    34214
    Firm
    Possis Medical, Inc
    FEI Number
    2183460
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 12, 2005
    Posted
    February 4, 2006
    Terminated
    November 8, 2006
    Address
    9055 Evergreen Blvd Nw, Minneapolis, MN, 55433-5833

    Description

    AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 USA.

    Reason

    It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model.

    Action

    An Advisory Notice was emailed to OUS Distributors 12/12/2005. The Advisory identifies the product, reason for recall and action Distributor should take. Distributors are to notify their customer who received the affected lot and return it to the Distributor. The Distributor is to open the outer box and inspect the catheter inside the sterile tray. Mislabeled units are to be returned to Possis.

    Distribution

    Lot was distributed to 3 OUS distributors located in Italy, United Kingdom and Netherlands.

    Quantity

    48