Device recall
Z-0705-06: Gambro Prisma M100 preset, Part No. 8353486.
FDA device recall · Class II · Gambro Renal Products, Inc.
Key facts
| Recall number (Z-number) | Z-0705-06 |
|---|---|
| Recall event | 34080 |
| Product | Gambro Prisma M100 preset, Part No. 8353486. |
| Product code | KDI |
| Recalling firm | Gambro Renal Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2012 |
| 510(k) numbers | K032431 |
| FEI number | 1713683 |
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