BEUDAMED
    FDA Recall Terminated

    XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length * Sterile/R * RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA

    Recall: Z-0888-06 · Initiated May 2, 2006

    Recall

    Recall Number
    Z-0888-06
    Event Number
    35342
    Firm
    Rita Medical Systems, Inc.
    FEI Number
    3017892510
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 2, 2006
    Posted
    May 31, 2006
    Terminated
    February 5, 2008
    Address
    1 Horizon Way, Manchester, GA, 31816-1749

    Description

    XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length * Sterile/R * RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA

    Reason

    Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker

    Action

    Consignees were first notified by telephone on 05/02/2006. A follow up letter was sent on 05/03/2006. The European Medical Device Agency, the Italian Competent Authority and British Standards Institution were notified by email on 05/03/2006.

    Distribution

    AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy

    Quantity

    19 units