BEUDAMED
    FDA Recall Terminated

    Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816

    Recall: Z-0403-2011 · Initiated September 27, 2010

    Recall

    Recall Number
    Z-0403-2011
    Event Number
    56876
    Firm
    Angiodynamics, INC
    FEI Number
    3017892510
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2010
    Posted
    November 17, 2010
    Terminated
    June 21, 2011
    Address
    1 Horizon Way, Manchester, GA, 31816-1749

    Description

    Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816

    Reason

    Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

    Action

    AngioDynamics issued a Notification of Medical Device Correction letter dated September 27, 2010 to customers. The notification served to make the customer aware of the mislabeling. Customers were instructed not to return the affected products. Customers can contact AngioDynamics at 1 800 772-6446 about this correction.

    Distribution

    Nationwide Distribution : Throughout the US.

    Quantity

    see line one.