BEUDAMED
    FDA Enforcement Class II Terminated

    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804

    Recall: Z-2261-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2261-2014
    Event ID
    68980
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    August 6, 2014
    Classification Date
    August 18, 2014
    Termination Date
    March 27, 2017
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619, United States

    Description

    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, 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).

    Code Info

    Lot 4731641 (exp. date 31-Mar-17)

    Distribution

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

    Quantity

    Domestic: 81 units; Foreign: 13 units