Device recall
Z-2226-2010: Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution…
FDA device recall · Class II · Fresenius Medical Care North America
Key facts
| Recall number (Z-number) | Z-2226-2010 |
|---|---|
| Recall event | 54546 |
| Product | Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA |
| Product code | KPO |
| Recalling firm | Fresenius Medical Care North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2011 |
| 510(k) numbers | K911459 |
| FEI number | 3001451489 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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