Events

Recall of Device Recall DuraMax

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

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
    60804
  • Event Risk Class
    Class 2
  • Event Number
    Z-0730-2012
  • Event Initiated Date
    2011-12-30
  • Event Date Posted
    2012-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106536
  • 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, hemodialysis, implanted - Product Code MSD
  • Reason
    The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
  • Action
    AngioDynamics sent an Urgent - Medical Device Recall letter dated December 30, 2011, via certified mail to all affected customers. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to examine inventory, segregate the recalled lots and return remaining inventory to the firm. The letter states that replacement product will be shipped upon receipt and confirmation of the returned product. Customers were advised to complete the Recall Reply Form included and fax to DuraMax Hemodialysis Catheter Recall Coordinator at 518-798-1360. For questions contact your local representative or call the Customer Service Manger at ANGIODYNAMICS Customer Service at 1-800-772-6446.

Device

Device Recall DuraMax
  • Model / Serial
    FG Lot Numbers: 539772, 547537, 554234
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (Nationwide)
  • Product Description
    Angiodynamics¿ DuraMax¿ VP Vascpak¿ Catheter Kit 15.5F x 55cm Chronic Hemodialysis VascPak¿ (with Cuff 50cm from Tip) --- Catalog No. [REF] 10302824 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY USA 12804 || Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis.
  • Manufacturer
    Angiodynamics Worldwide Headquarters

Manufacturer

Angiodynamics Worldwide Headquarters
  • Manufacturer Address
    Angiodynamics Worldwide Headquarters, 14 Plaza Drive, Latham NY 12110-3421
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA