FDA Device recall Z-0078-2017
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or t…
- FDA Device
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or t… by Biocompatibles U K, citing 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 w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0078-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-21 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biocompatibles U K |
| Distribution | CA, FL, IL, IN, KY, MA, MD, MI, MN, NV, NY, OH, OR, PA, TX, WA, WI |
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.
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.
Identifiers
| code_info | Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0078-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.