Device recall
Z-2200-2014: Prisma HF1000 preset (new design). Product number 107639. Each set is packaged…
FDA device recall · Class II · Gambro Renal Products, Incorporated
Key facts
| Recall number (Z-number) | Z-2200-2014 |
|---|---|
| Recall event | 68788 |
| Product | Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box |
| Product code | KDI |
| Recalling firm | Gambro Renal Products, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2015 |
| 510(k) numbers | K011221 |
| FEI number | 1713683 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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