BEUDAMED
    FDA Recall Terminated

    Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816. Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.

    Recall: Z-3073-2011 · Initiated August 30, 2010

    Recall

    Recall Number
    Z-3073-2011
    Event Number
    59680
    Firm
    Angiodynamics, INC
    FEI Number
    3017892510
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    August 30, 2010
    Posted
    August 24, 2011
    Terminated
    March 12, 2012
    Address
    1 Horizon Way, Manchester, GA, 31816-1749

    Description

    Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816. Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.

    Reason

    The labeling contains errors which result in the products being misbranded

    Action

    AngioDynamics, Inc. sent out a "Medical Device Recall" letter dated August 30, 2010 to all affected customers. The letter included; products affected, problem and asked them to return the product back to AngioDynamics. Customers were asked to fill out and return the included Recall Reply Form. For question on this recall contact AngioDynamics at (800) 772-6446.

    Distribution

    Worldwide Distribution: (USA) Nationwide distribution and the countries of Austria, China, Denmark, Egypt, France Germany, India, Italy, Latvia, Netherlands, Poland, Russian Federation, South Africa, Switzerland and the United Kingdom

    Quantity

    527 units