Events

Recall of Device Recall PULSESPRAY 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
    55715
  • Event Risk Class
    Class 2
  • Event Number
    Z-1707-2010
  • Event Initiated Date
    2010-05-17
  • Event Date Posted
    2010-05-27
  • 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=91638
  • 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
    This lot was packaged with the wrong occluding ball guidewire. the pulsespray catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball guidewire.
  • Action
    Angiodynamics issued an "Urgent Medical Device Recall" notification (dated 5/11/10) to user accounts via Certified Mail. Consignees were asked to identify, segregate and return all affected product to the firm in addition to sending in a completed Reply Form via fax. For further information, contact Angiodynamics Customer Service at 1-800-772-6446.

Device

Device Recall PULSESPRAY INFUSION SYSTEM
  • Model / Serial
    Lot Number: 991437.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (AR, NY, PA, MI, MN, LA and WA), Spain, Austria and Denmark.
  • Product Description
    PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804. || Infusion Catheter.
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

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