Events

Recall of Flexible Implant tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems.

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
    31941
  • Event Risk Class
    Class 2
  • Event Number
    Z-0921-05
  • Event Initiated Date
    2005-04-14
  • Event Date Posted
    2005-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38785
  • 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
    System, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
  • Reason
    A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
  • Action
    The recalling firm notified end users by Customer Technical Bulletin on 4/14/05. The bulletin advised of potential for the blind end of the implant tube to become separated with the possible effect of the tube end being inhaled by a patient. Consignees were instructed to stop using product and return for replacement. The firm''s bulletin is also available on the company website.

Device

Flexible Implant tube
  • Model / Serial
    Lot 04/21/1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to direct accounts in CT, MI, PA, CO, VT and MO. Product was additionally sold to foreign accounts in internationally.
  • Product Description
    Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or contained in the Flexible Interstitial Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems
  • Manufacturer Address
    Varian Medical Systems, 700 Harris Street, Suite 109, Charlottesville VA 22903-4584
  • Source
    USFDA