Events

Recall of AngioDynamics VenaCure EVLT Procedure Kits

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
    65119
  • Event Risk Class
    Class 2
  • Event Number
    Z-1406-2013
  • Event Initiated Date
    2013-04-30
  • Event Date Posted
    2013-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117930
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Reason
    Angiodynamics inc., is recalling micro introducer kits and venacure evlt nevertouch procedure kits, because the potential exists that the micro introducer (sheath/dilator) packaged within the kit could be the wrong french size.
  • Action
    AngioDynamics sent an Urgent Medical Device Recall letter dated April 29, 2013, to all customers by Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to lmmediately remove the affected product from inventory and call AngioDynamics, Inc. Customer Service at 1-800-772-6446 to obtain a replacement or credit for your returned product and to obtain UPS Account Number to return the package via second day delivery. Customers are instructed to segregate and return all affected devices to: AngioDynamics 603 Queensbury Avenue Queensbury, NY 12804 Attn: Micro Introducer and VenaCure EVLT NeverTouch Procedure Kits Recall Coordinator. Write the RMA number on the shipping box (Provied on the Recall Verification Tracking Form). Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on the notification form and the Reply Verification Form. Send the Reply Verification form to AngioDynamics either via Fax or Emai. Fax Reply Verification Tracking Form to: Attn: Micro Introducer and VenaCure EVLT NeverTouch Procedure Kits Recall Coordinatory Fax number 1-518-798-1360 or Email Reply Verification Tracking Form to: rdenino@angiodynamics.com.

Device

AngioDynamics VenaCure EVLT Procedure Kits
  • Model / Serial
    Corresponding Lot numbers: 1) 588948, 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN
  • Product Description
    AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: || 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. || Product Usage: || This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
  • 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