BEUDAMED
    FDA Recall Terminated

    PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804. Infusion Catheter.

    Recall: Z-1707-2010 · Initiated May 17, 2010

    Recall

    Recall Number
    Z-1707-2010
    Event Number
    55715
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 17, 2010
    Posted
    May 27, 2010
    Terminated
    July 25, 2012
    Address
    603 Queensbury Avenue, Queensbury, NY, 12804

    Description

    PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804. Infusion Catheter.

    Reason

    This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball guidewire.

    Action

    Angiodynamics issued an "Urgent Medical Device Recall" notification (dated 5/11/10) to user accounts via Certified Mail. Consignees were asked to identify, segregate and return all affected product to the firm in addition to sending in a completed Reply Form via fax. For further information, contact Angiodynamics Customer Service at 1-800-772-6446.

    Distribution

    Worldwide Distribution -- United States (AR, NY, PA, MI, MN, LA and WA), Spain, Austria and Denmark.

    Quantity

    20 units