Events

Recall of Device Recall Habib, 4x Kit 4401L

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
    59680
  • Event Risk Class
    Class 2
  • Event Number
    Z-3074-2011
  • Event Initiated Date
    2010-08-30
  • Event Date Posted
    2011-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103267
  • 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
    Electrosurgica Coagulation Accessory - Product Code GEI
  • Reason
    The labeling contains errors which result in the products being misbranded.
  • Action
    AngioDynamics, Inc. sent out a "Medical Device Recall" letter dated August 30, 2010 to all affected customers. The letter included; products affected, problem and asked them to return the product back to AngioDynamics. Customers were asked to fill out and return the included Recall Reply Form. For question on this recall contact AngioDynamics at (800) 772-6446.

Device

Device Recall Habib, 4x Kit 4401L
  • Model / Serial
    Catalog number: 4401L, Batch number: 511829, 511830, 513063 513519 and 513789.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: (USA) Nationwide distribution and the countries of Austria, China, Denmark, Egypt, France Germany, India, Italy, Latvia, Netherlands, Poland, Russian Federation, South Africa, Switzerland and the United Kingdom
  • Product Description
    Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). || AngioDynamics, Inc., || One Horizon Way, || Manchester, GA 30816. || Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
  • Manufacturer
    Angiodynamics, INC

Manufacturer

Angiodynamics, INC
  • Manufacturer Address
    Angiodynamics, INC, 1 Horizon Way, Manchester GA 31816-1749
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA