BEUDAMED
    FDA Recall Terminated

    ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Model/REF Number 70035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 603 Queensbury, NY 12804.

    Recall: Z-1733-2010 · Initiated April 30, 2010

    Recall

    Recall Number
    Z-1733-2010
    Event Number
    55713
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    April 30, 2010
    Posted
    May 28, 2010
    Terminated
    July 25, 2012
    Address
    603 Queensbury Avenue, Queensbury, NY, 12804

    Description

    ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Model/REF Number 70035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 603 Queensbury, NY 12804.

    Reason

    Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition.

    Action

    Angiodynamics, Inc. issued an "Urgent Medical Device Recall" notification (dated 4/28/10). Customers were advised of the affected product and instructed to return all recalled product to the firm. For further information, contact Angiodynamics, Inc. Customer Service at 1-800-772-6446.

    Distribution

    Distributed Nationwide and to Italy

    Quantity

    741