Events

Recall of Device Recall Vortex MPP5SDT Port

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
    59680
  • Event Risk Class
    Class 2
  • Event Number
    Z-3072-2011
  • Event Initiated Date
    2010-08-30
  • Event Date Posted
    2011-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103265
  • 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
    Intravascular Catheter, Subcutaneous - Product Code LJT
  • Reason
    The labeling contains errors which result in the products being misbranded.
  • Action
    AngioDynamics, Inc. sent out a "Medical Device Recall" letter dated August 30, 2010 to all affected customers. The letter included; products affected, problem and asked them to return the product back to AngioDynamics. Customers were asked to fill out and return the included Recall Reply Form. For question on this recall contact AngioDynamics at (800) 772-6446.

Device

Device Recall Vortex MPP5SDT Port
  • Model / Serial
    Catalog number: MP-P5SDT, Batch number: 513796 and 517058
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: (USA) Nationwide distribution and the countries of Austria, China, Denmark, Egypt, France Germany, India, Italy, Latvia, Netherlands, Poland, Russian Federation, South Africa, Switzerland and the United Kingdom
  • Product Description
    Vortex MP Port Single Titanium Port with Attachable (5Fr) Silicone Catheter, || AngioDynamics, Inc., || One Horizon Way, || Manchester, GA 30816 || Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
  • 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