Recall Z-1162-2013
Sirtex Medical Limited · initiated February 27, 2013
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
Codes / lots: Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10
Reason for recall
Incorrect expiration date
FDA-determined cause: Labeling False and Misleading
Action taken
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.
Details
- Recall number
- Z-1162-2013
- Initiated
- February 27, 2013
- Posted by FDA
- April 23, 2013
- Terminated
- March 30, 2015
- Product code
- NAW – Microspheres Radionuclide
- Quantity
- 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.
- Recalling firm
- Sirtex Medical Limited