Device recall
Z-2401-2008: Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO…
FDA device recall · Class III · Edwards Lifesciences Research Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2401-2008 |
|---|---|
| Recall event | 49049 |
| Product | Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614 Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours. |
| Product code | DWF |
| Recalling firm | Edwards Lifesciences Research Medical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 23, 2008 |
| 510(k) numbers | K831769 |
| 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