Device recall
Z-1101-06: Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-1101-06 |
|---|---|
| Recall event | 35335 |
| Product | Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244. |
| Product code | DWF |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 3, 2008 |
| 510(k) numbers | K990772 |
| FEI number | 2210968 |
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