Events

Recall of ANGIODYNAMICS BENEPHIT(TM) XT Infusion System

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
    55713
  • Event Risk Class
    Class 2
  • Event Number
    Z-1734-2010
  • Event Initiated Date
    2010-04-30
  • Event Date Posted
    2010-05-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91635
  • 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
    Benephit infusion catheters may exhibit a hole or tear in the primary sterile barrier packaging. the product is intended to be sterile. breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition.
  • Action
    Angiodynamics, Inc. issued an "Urgent Medical Device Recall" notification (dated 4/28/10). Customers were advised of the affected product and instructed to return all recalled product to the firm. For further information, contact Angiodynamics, Inc. Customer Service at 1-800-772-6446.

Device

ANGIODYNAMICS BENEPHIT(TM) XT Infusion System
  • Model / Serial
    Batch Number: P909231.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide and to Italy
  • Product Description
    ANGIODYNAMICS BENEPHIT(TM) CV Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Catalog/Model/REF Number 60035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 603 Queensbury, NY 12804.
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Manufacturer Address
    Angiodynamics, Inc., 603 Queensbury Avenue, Queensbury NY 12804
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA