BEUDAMED
    FDA Recall Terminated

    Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or contained in the Flexible Interstitial Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.

    Recall: Z-0921-05 · Initiated April 14, 2005

    Recall

    Recall Number
    Z-0921-05
    Event Number
    31941
    Firm
    Varian Medical Systems
    FEI Number
    3000206172
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 14, 2005
    Posted
    June 22, 2005
    Terminated
    August 22, 2005
    Address
    700 Harris Street, Suite 109, Charlottesville, VA, 22903-4584

    Description

    Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or contained in the Flexible Interstitial Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.

    Reason

    A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.

    Action

    The recalling firm notified end users by Customer Technical Bulletin on 4/14/05. The bulletin advised of potential for the blind end of the implant tube to become separated with the possible effect of the tube end being inhaled by a patient. Consignees were instructed to stop using product and return for replacement. The firm''s bulletin is also available on the company website.

    Distribution

    Product was distributed to direct accounts in CT, MI, PA, CO, VT and MO. Product was additionally sold to foreign accounts in internationally.

    Quantity

    33 devices in domestic distribution