FDA Device recall Z-1162-2013
Sirtex SIR-yttrium 90 microspheres (Radionuclide)
- FDA Device
- Class III
- terminated
- Published 2013-05-01
On 2013-05-01 the FDA classified a Class III recall of Sirtex SIR-yttrium 90 microspheres (Radionuclide) by Sirtex Medical, citing incorrect expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1162-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-27 |
| Published | 2013-05-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sirtex Medical |
| Distribution | US |
Product
Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
Reason
Incorrect expiration date
Identifiers
| code_info | Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1162-2013%22
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