BEUDAMED
    FDA Recall Terminated

    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804

    Recall: Z-2260-2014 · Initiated August 6, 2014

    Recall

    Recall Number
    Z-2260-2014
    Event Number
    68980
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 6, 2014
    Posted
    August 18, 2014
    Terminated
    March 27, 2017
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    Description

    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804

    Reason

    AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).

    Action

    AngioDynamics sent an URGENT MEDICAL DEVICE RECALL Letter dated August 6, 2014, to all affected customers via Federal Express. Consignees were instructed to segregate and return all affected devices to AngioDynamics, Inc. and complete and return the Reply Verification Tracking Form, provided in the recall notification. Those customers with the affected product were also instructed to call AngioDynamics Customer Service at 1-800-772-6446. For questions regarding this recall call 718-742-4571.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.

    Quantity

    Domestic: 70 units; Foreign: 27 units