Device recall
Z-0078-2008: Spectra Optia apheresis system, a blood component separator. Part No. 61000…
FDA device recall · Class II · Gambro BCT, Inc.
Key facts
| Recall number (Z-number) | Z-0078-2008 |
|---|---|
| Recall event | 44915 |
| Product | Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215. |
| Product code | LKN |
| Recalling firm | Gambro BCT, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2008 |
| 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