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U.S. Department of Health and Human Services

Class 2 Device Recall TheraSphere(R) YTTRIUM90 GLASS MICROSPHERE

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  Class 2 Device Recall TheraSphere(R) YTTRIUM90 GLASS MICROSPHERE see related information
Date Initiated by Firm September 21, 2015
Create Date October 13, 2016
Recall Status1 Terminated 3 on October 17, 2016
Recall Number Z-0078-2017
Recall Event ID 75350
HDE Number H980006 
Product Classification Microspheres radionuclide - Product Code NAW
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.
Code Information Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)
Recalling Firm/
Manufacturer		 Biocompatibles U.K., Ltd.
Bortoli House
Weydon Lane; Old Farnham Lane
Farnham United Kingdom
For Additional Information Contact Janet Bukovcan
613-801-1848
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
HDE Database HDEs with Product Code = NAW and Original Applicant = Boston Scientific Corporation
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