Events

Recall of Device Recall BENEPHIT CV Infusion System

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
    61123
  • Event Risk Class
    Class 2
  • Event Number
    Z-1114-2012
  • Event Initiated Date
    2012-02-06
  • Event Date Posted
    2012-02-28
  • 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=107342
  • 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
    The benephit cv infusion system contains a sheath y connector that has the potential to develop cracks.
  • Action
    Field Safety Notices (FSNs), entitled Urgent - Medical Device Recall, were sent to consignees on 02/06/2012 via USPS certified mail, return receipt requested. The letters identified the affected devices, the issue, hazard involved, and actions to be taken by the customer and AngioDynamics. The FSN directs consignees to identify and segregate the recalled lots, returning any affected product to AngioDynamics, Inc., Queensbury, NY 12804. The Recall Reply Form should be completed and faxed to 518-798-1360. --- If customers have distributed the affected product/lot, they are instructed to inform their customers of this recall action immediately, and then return the recalled units. --- If customers have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please contact the local sales representative or call Julie Blair, Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. Customers may also e-mail questions to customerservice@angiodynamics.com

Device

Device Recall BENEPHIT CV Infusion System
  • Model / Serial
    Lot 551092
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Florida, Iowa, Maryland, New York, and Texas.
  • Product Description
    AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60040 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. || Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries.
  • 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