Events

Recall of Device Recall Sirtex SIRyttrium 90 microspheres (Radionuclide)

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

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
    64508
  • Event Risk Class
    Class 3
  • Event Number
    Z-1162-2013
  • Event Initiated Date
    2013-02-27
  • Event Date Posted
    2013-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116369
  • 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
    Microspheres radionuclide - Product Code NAW
  • Reason
    Incorrect expiration date.
  • Action
    Sirtex notified medical end users on 2/27/13 via email correspondence with a copy of the recall letter attached. This was done to ensure advice was received at the same time that the goods were arriving. Hard copies of the recall letter, which were stamped "copy", were also sent to the individual facilities via UPS, processed for delivery Thursday, 28 February, 2013. Medical end users were advised in the recall letter to contact the US Customer Service staff at (888) 474-7839 x 702 to arrange for the pick-up if they decide to return the unused product.

Device

Device Recall Sirtex SIRyttrium 90 microspheres (Radionuclide)
  • Model / Serial
    Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10
  • Product Classification
    Radiology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CT, GA, ID, IL,KY, LA, MD, ME, MO, MT, NJ, NV, WA, and WV.
  • Product Description
    Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. || Indicated for the treatment of unresectable metastatic liver tumors.
  • Manufacturer
    Sirtex Medical Limited

Manufacturer

Sirtex Medical Limited
  • Manufacturer Address
    Sirtex Medical Limited, Centrecourt Business Park,, Unit D4, 25-27, Paul Street North, North Ryde, New South Wales Australia
  • Manufacturer Parent Company (2017)
    Sirtex Medical Limited
  • Source
    USFDA