Recall of Device Recall AngioDynamics Morpheus Smart PICC CT

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
    60909
  • Event Risk Class
    Class 2
  • Event Number
    Z-0878-2012
  • Event Initiated Date
    2012-01-09
  • Event Date Posted
    2012-01-26
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-02-05
  • Event Source
    USFDA
  • Event Source URL
  • 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,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Reason
    The red luer on the morpheus ct picc (peripherally inserted central catheter) has the potential to crack during use of the product.
  • Action
    AngioDynamics, Inc. sent an Urgent - Medical Device Recall letter dated January 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and segragate the recalled affected product. Complete the enclosed Morpheus Ct PICC Recall Reply Form and fax it to the attention of the Morpheus CT PICC Recall Coordinator at 518-798-1360. If customers do not have any affected product remaining in their possession they should fill out the attached form noting zero quantity to be returned and fax the form to 518-798-1360. If customers distributed the affected product, they should inform their customers of this recall action immediately and have them return the recalled units to them. For any questions regarding this recall call 1-800-772-6446 or e-mail customerservice@angiodynamics.com.

Device

  • Model / Serial
    FG Lot Number: 552392, 554557
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    AngioDynamics Morpheus¿ Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102604 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 || indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Angiodynamics Worldwide Headquarters, 14 Plaza Drive, Latham NY 12110-3421
  • Manufacturer Parent Company (2017)
  • Source
    USFDA