Device recall
Z-2994-2011: XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001…
FDA device recall · Class II · Therakos, Inc.
Key facts
| Recall number (Z-number) | Z-2994-2011 |
|---|---|
| Recall event | 58744 |
| Product | XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT Single-use, disposable, closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a… |
| Product code | LNR |
| Recalling firm | Therakos, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2015 |
| PMA numbers | P860003, P860003S031, P860003S051 |
| 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