Recall Z-0078-2017 ยท NAW Microspheres Radionuclide
Biocompatibles U.K., Ltd.
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.
| Date | Sep 21, 2015 |
| Status | Terminated |
| 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. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.