Device product
Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
Z-1162-2013
Product summary
- Event
- Event 64508
- Status
- Terminated
- Classification
- Class III
- Quantity
- 21 doses
- Official record key
device-enforcement:Z-1162-2013
Official wording
Reason: Incorrect expiration date
Code information: Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10
Distribution pattern: 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.
Derived failure modes
-
Unknown
Incorrect expiration date