BEUDAMED
    FDA Recall Terminated

    50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200 DALLAS, TEXAS 75205 For use in humans. No indication of use is on the label. However, the device can be used for infusion.

    Recall: Z-1625-2012 · Initiated May 10, 2012

    Recall

    Recall Number
    Z-1625-2012
    Event Number
    61859
    Firm
    MEDDEV USA, INC.
    FEI Number
    3009257101
    Product Code
    KDH
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    May 10, 2012
    Posted
    May 17, 2012
    Terminated
    August 15, 2013
    Address
    100 Highland Park Vlg, FL 200, Dallas, TX, 75205-2720

    Description

    50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200 DALLAS, TEXAS 75205 For use in humans. No indication of use is on the label. However, the device can be used for infusion.

    Reason

    The device was marketed without a 510(k) and is not sterile.

    Action

    MEDDEV USA, Inc decided to recall and notified their customer by phone on 05/10/12. Customers were instructed to return the entire shipment to MEDDEV . For questions regarding this recall call 214-692-3559.

    Distribution

    Nationwide Distribution including Illinois

    Quantity

    20 units