BEUDAMED
    FDA Recall Terminated

    RITA Starburst MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816

    Recall: Z-0754-2007 · Initiated April 3, 2007

    Recall

    Recall Number
    Z-0754-2007
    Event Number
    37742
    Firm
    Rita Medical Systems, Inc.
    FEI Number
    3017892510
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 3, 2007
    Posted
    April 19, 2007
    Terminated
    January 20, 2010
    Address
    1 Horizon Way, Manchester, GA, 31816-1749

    Description

    RITA Starburst MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816

    Reason

    The product may have a cracked tray which can compromise the sterility of the product.

    Action

    Notification by letter of the AngioDynamics, Inc. sales force and the domestic and international distributors began on April 2, 2007. They were asked to return all affected devices to the Manchester, GA division of AngioDynamics, Inc. A reply form was attached to be completed and returned via fax to AngioDynamics.

    Distribution

    Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.

    Quantity

    2021 devices