Device recall
Z-0577-2007: EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery…
FDA device recall · Class II · Ekos Corp
Key facts
| Recall number (Z-number) | Z-0577-2007 |
|---|---|
| Recall event | 37314 |
| Product | EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. EndoWave… |
| Product code | KRA |
| Recalling firm | Ekos Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2008 |
| 510(k) numbers | K060422 |
| FEI number | 3001627457 |
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