• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Sirtex SIRyttrium 90 microspheres (Radionuclide)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 3 Recall
Sirtex SIRyttrium 90 microspheres (Radionuclide)
see related information
Date Posted April 23, 2013
Recall Status1 Open
Recall Number Z-1162-2013
Recall Event ID 64508
Premarket Approval
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
Manufacturer Reason
for Recall
Incorrect expiration date
FDA Determined
Cause 2
MISBRANDING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NAW and Applicant = SIRTEX MEDICAL LIMITED
-
-