Device recall
Z-2199-2011: The Operating Manual contains the Operating Instructions for AS 104 Blood Cell…
FDA device recall · Class II · Fresenius Kabi, LLC
Key facts
| Recall number (Z-number) | Z-2199-2011 |
|---|---|
| Recall event | 58596 |
| Product | The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS… |
| Product code | LKN |
| Recalling firm | Fresenius Kabi, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 6, 2011 |
| 510(k) numbers | K961706 |
| FEI number | 3007344667 |
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