Biocompatibles U.K., Ltd.: Medical Device Recall in 2016 - (Recall #: Z-0078-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 21, 2015

Date Posted: October 19, 2016

Recall Number: Z-0078-2017

Event ID: 75350

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.

Status: Terminated

Product Quantity: 64 doses

Code Information:

Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated