Z-0078-2017 Class II Terminated
FDA device recall Z-0078-2017 was initiated by Biocompatibles U.K., Ltd. on September 21, 2015 and is designated Class II. 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. The recall status is terminated (terminated October 17, 2016). Affected quantity: 64 doses.
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2016
- Initiation Date
- September 21, 2015
- Termination Date
- October 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 doses
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.
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
Code Information
Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)