Device recall
Z-1894-2008: Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8…
FDA device recall · Class II · Edwards Lifesciences Research Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1894-2008 |
|---|---|
| Recall event | 47204 |
| Product | Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x 11.5 cm, REF DIIFEMII008V, Cardiopulmonary bypass tubing. |
| Product code | DWF |
| Recalling firm | Edwards Lifesciences Research Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 2008 |
| 510(k) numbers | K033464 |
| FEI number | 1713910 |
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