Device recall
Z-1683-2012: Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System…
FDA device recall · Class II · CaridianBCT, Inc.
Key facts
| Recall number (Z-number) | Z-1683-2012 |
|---|---|
| Recall event | 57371 |
| Product | Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell… |
| Product code | LKN |
| Recalling firm | CaridianBCT, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2012 |
| 510(k) numbers | K103090 |
| 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