Recall Z-0078-2017— Biocompatibles U.K., Ltd.
Class II · Terminated
Class II FDA medical device recall by Biocompatibles U.K., Ltd., initiated 2015-09-21, terminated 2016-10-17. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Biocompatibles U.K., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-21
- Terminated
- 2016-10-17
- Firm location
- Farnham, N/A, United Kingdom
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.