Device recall
Z-0111-06: Lysus Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System…
FDA device recall · Class II · Ekos Corp
Key facts
| Recall number (Z-number) | Z-0111-06 |
|---|---|
| Recall event | 33402 |
| Product | Lysus Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the… |
| Product code | KRA |
| Recalling firm | Ekos Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2005 |
| 510(k) numbers | K042456 |
| 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