BEUDAMED
    FDA Enforcement Class II Terminated

    Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

    Recall: Z-0760-2013 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0760-2013
    Event ID
    61879
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Varian Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2013
    Initiation Date
    April 12, 2012
    Classification Date
    January 31, 2013
    Termination Date
    April 10, 2014
    Address
    700 Harris St Ste 109, Charlottesville, VA, 22903-4584, United States

    Description

    Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

    Reason

    A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

    Code Info

    All lots

    Distribution

    US Nationwide Distribution

    Quantity

    152 units