Z-0078-2017Class II

TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as...

Name: Z-0078-2017 TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as...
Creator: Biocompatibles U.K., Ltd.
Published: 2015-09-21
License: https://open.fda.gov/license/

BIOCOMPATIBLES U.K. Limited, a BTG Company / initiated 2015-09-21 / Terminated / root cause: packaging

FDA source

Biocompatibles U.K., Ltd. began a recall of TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in... on 2015-09-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0078-2017
Classification: Class II
Status: Terminated
Initiated: 2015-09-21
Posted: 2016-10-13
Terminated: 2016-10-17
Recalling firm: BIOCOMPATIBLES U.K. Limited, a BTG Company
Product: 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.
Product code: NAW Microspheres Radionuclide
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Packaging
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.
Quantity in commerce: 64 doses
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 codes and lots: Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0078-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0078-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13

Product code NAW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)