Device recall
Z-2196-2011: Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20…
FDA device recall · Class II · Edwards Lifesciences Llc
Key facts
| Recall number (Z-number) | Z-2196-2011 |
|---|---|
| Recall event | 57951 |
| Product | Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. The cannula perfuses blood to the ascending aorta during short-term (<6 hours) cardiopulmonary bypass procedures. The device is a Duraflo coated cannula… |
| Product code | DWF |
| Recalling firm | Edwards Lifesciences Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2011 |
| 510(k) numbers | K033463 |
| 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