Device recall
Z-2190-2012: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For…
FDA device recall · Class II · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-2190-2012 |
|---|---|
| Recall event | 62278 |
| Product | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring. |
| Product code | DYG |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 17, 2014 |
| 510(k) numbers | K810352 |
| FEI number | 2015691 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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