Device recall
Z-0191-2012: Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A…
FDA device recall · Class II · Caridian BCT, Incorporated
Key facts
| Recall number (Z-number) | Z-0191-2012 |
|---|---|
| Recall event | 60174 |
| Product | Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges. |
| Product code | LKN |
| Recalling firm | Caridian BCT, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 1, 2013 |
| 510(k) numbers | K071079 |
| FEI number | 1000117351 |
At a glance
- 1–9 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