Device recall
Z-0595-2012: Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis…
FDA device recall · Class II · Therakos, Inc.
Key facts
| Recall number (Z-number) | Z-0595-2012 |
|---|---|
| Recall event | 60628 |
| Product | Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the… |
| Product code | LNR |
| Recalling firm | Therakos, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 27, 2014 |
| 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