Events

Recall of UniFuse Infusion System with Cooper Wire

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Angiodynamics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68980
  • Event Risk Class
    Class 2
  • Event Number
    Z-2262-2014
  • Event Initiated Date
    2014-08-06
  • Event Date Posted
    2014-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129197
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, continuous flush - Product Code KRA
  • 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.

Device

UniFuse Infusion System with Cooper Wire
  • Model / Serial
    Lot 4762513 (exp. date 31-May-17)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.
  • Product Description
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Manufacturer Address
    Angiodynamics, Inc., 603 Queensbury Ave, Queensbury NY 12804-7619
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA