Device recall
Z-1822-2026: Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit…
FDA device recall · Class II · THERAKOS DEVELOPMENT LIMITED
Key facts
| Recall number (Z-number) | Z-1822-2026 |
|---|---|
| Recall event | 98558 |
| Product | Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via… |
| Product code | LNR |
| Recalling firm | THERAKOS DEVELOPMENT LIMITED |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P860003 |
| FEI number | 3036773437 |
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