FDAFDA · Food and drugs·Recall number Z-0078-2017
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.
Published October 19, 2016 · Recall initiated: September 21, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Biocompatibles U.K., Ltd.
- Distributor
- 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
- Lot
- Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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