Events

Recall of TheraSphere(R) YTTRIUM90 GLASS MICROSPHERE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biocompatibles U.K., Ltd..

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
    75350
  • Event Risk Class
    Class 2
  • Event Number
    Z-0078-2017
  • Event Initiated Date
    2015-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150105
  • 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
    One mislabeled dose of therasphere¿ y-90 glass microspheres, which was shipped to hong kong (total radioactivity incorrect). the product ws labeled as 10 gbq and the actual does was 5 gbq.
  • Action
    Biocompatibles UK Ltd sent an Urgent Field Safety Notice dated September 21, 2015, to all affected customers. The firm did not request return or destruction of the product. Customers with questions were instructed to call 613-410-1870. For questions regarding this recall call 613-801-1848.

Device

TheraSphere(R) YTTRIUM90 GLASS MICROSPHERE
  • Model / Serial
    Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)
  • Product Classification
    Radiology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US to CA, FL, IL, WI, IN, OR, PA, MA, NY, KY, TX, MI, MD, NV, WA, OH, MN, and Internationally to Germany, Turkey, Hong Kong, Italy, Portugal
  • Product Description
    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION || TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
  • Manufacturer
    Biocompatibles U.K., Ltd.

Manufacturer

Biocompatibles U.K., Ltd.
  • Manufacturer Address
    Biocompatibles U.K., Ltd., Bortoli House, Weydon Lane; Old Farnham Lane, Farnham United Kingdom
  • Manufacturer Parent Company (2017)
    Btg Plc
  • Source
    USFDA