Device recall
Z-1367-2008: Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe…
FDA device recall · Class II · Gambro Renal Products, Inc.
Key facts
| Recall number (Z-number) | Z-1367-2008 |
|---|---|
| Recall event | 45950 |
| Product | Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401 |
| Product code | KDI |
| Recalling firm | Gambro Renal Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 3, 2012 |
| 510(k) numbers | K001156 |
| 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