BEUDAMED
    FDA Recall Terminated

    GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany Product Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin

    Recall: Z-2991-2011 · Initiated July 13, 2011

    Recall

    Recall Number
    Z-2991-2011
    Event Number
    59401
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 13, 2011
    Posted
    August 10, 2011
    Terminated
    June 20, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany Product Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin

    Reason

    Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.

    Action

    Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated July 13, 2011 to all possibly affected customers. This notification supplements and modifies the previous "Customer Technical Bulletins" originally sent in September 2008. The initial Customer Technical Bulletins informed customers of the possibility that needle tips cans crack and separate. It also reminded users that the product has a limited life and to check needles prior to use as per instructions. Current correction notice letter instruct customers to stop using any plastic needles in inventory with lot numbers C01 to D01 and those with lot numbers starting with H or I. The letter also request that the recalled products be returned to Varian BrachyTherapy for replacement. The letters include information as to where the lot number is located on the device. All appropriate personnel should be notified of the correction notice. Contact information is provided for all geographical areas. USA contact for questions or concerns is 1-800-360-7909.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Austria, Bangladesh, Belgium, Brazil, Canada, Columbia, Cyprus, Czech Republic Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, India, Japan, Kazahastan, Kuwait, Lebanon, Macedonia, Mexico, Moldova, Nepal New Zealand, Norway, Pakistan, Philippines, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Arab Emirates Uruguay, United Kingdom, and Venezuela.

    Quantity

    601 - all sizes.