Events

Recall of Device Recall RITA Main Cable

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
    65439
  • Event Risk Class
    Class 2
  • Event Number
    Z-1675-2013
  • Event Initiated Date
    2013-06-11
  • Event Date Posted
    2013-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118894
  • 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
    Electrosurgical, cutting & coagulation &accessories; - Product Code GEI
  • Reason
    The rita main cable product contains the incorrect instructions for use.
  • Action
    Consignees were notified via certified mail on 06/11/2013 with an "Urgent Medical Device Field Safety Correction" notification. This included the correct Instructions for Use and the recommended actions.

Device

Device Recall RITA Main Cable
  • Model / Serial
    Catalog #700-101892, Lot number: 30.12
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
  • Product Description
    AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
  • 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