Device recall
Z-1322-2016: The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog…
FDA device recall · Class II · Therakos Inc
Key facts
| Recall number (Z-number) | Z-1322-2016 |
|---|---|
| Recall event | 73012 |
| Product | The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive… |
| Product code | LNR |
| Recalling firm | Therakos Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 14, 2016 |
| PMA numbers | P860003 |
| FEI number | 2523595 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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