Device recall
Z-3028-2018: Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
FDA device recall · Class II · SPS Sterilization, Inc
Key facts
| Recall number (Z-number) | Z-3028-2018 |
|---|---|
| Recall event | 80317 |
| Product | Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. |
| Product code | DWF |
| Recalling firm | SPS Sterilization, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2018 |
| 510(k) numbers | K123370 |
| FEI number | 3005057969 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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