Device recall
Z-1162-2013: Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the…
FDA device recall · Class III · Sirtex Medical Limited
Key facts
| Recall number (Z-number) | Z-1162-2013 |
|---|---|
| Recall event | 64508 |
| Product | Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors. |
| Product code | NAW |
| Recalling firm | Sirtex Medical Limited |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 30, 2015 |
| PMA numbers | P990065 |
| FEI number | 3003428886 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database