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U.S. Department of Health and Human Services

Class 3 Device Recall Sirtex SIRyttrium 90 microspheres (Radionuclide)

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  Class 3 Device Recall Sirtex SIRyttrium 90 microspheres (Radionuclide) see related information
Date Initiated by Firm February 27, 2013
Date Posted April 23, 2013
Recall Status1 Terminated 3 on March 30, 2015
Recall Number Z-1162-2013
Recall Event ID 64508
PMA Number p990065 
Product Classification Microspheres radionuclide - Product Code NAW
Product Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001.

Indicated for the treatment of unresectable metastatic liver tumors.
Code Information Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10
Recalling Firm/
Manufacturer		 Sirtex Medical Limited
Centrecourt Business Park,
Unit D4, 25-27, Paul Street North
North Ryde, New South Wales Australia
Manufacturer Reason
for Recall		 Incorrect expiration date
FDA Determined
Cause 2		 Labeling False and Misleading
Action Sirtex notified medical end users on 2/27/13 via email correspondence with a copy of the recall letter attached. This was done to ensure advice was received at the same time that the goods were arriving. Hard copies of the recall letter, which were stamped "copy", were also sent to the individual facilities via UPS, processed for delivery Thursday, 28 February, 2013. Medical end users were advised in the recall letter to contact the US Customer Service staff at (888) 474-7839 x 702 to arrange for the pick-up if they decide to return the unused product.
Quantity in Commerce 21 doses
Distribution Nationwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CT, GA, ID, IL,KY, LA, MD, ME, MO, MT, NJ, NV, WA, and WV.
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.
PMA Database PMAs with Product Code = NAW and Original Applicant = Sirtex Medical Pty Ltd
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