Device recall
Z-2083-2025: Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog…
FDA device recall · Class I · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-2083-2025 |
|---|---|
| Recall event | 96943 |
| Product | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No |
| Product code | DQR |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K140208 |
| FEI number | 2015691 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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