Recall Z-0110-06 ยท KRA Catheter, Continuous Flush
Ekos Corp
The Lysus Infusion System - Catheter Interface Cable. 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 UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus Infusion System cons
| Date | Nov 1, 2005 (initiated Sep 21, 2004) |
| Status | Terminated |
| Reason | The 100V board in the catheter interface cable pod failed during use. The PT-3 control unit would not recognize the catheter interface cable. |
| Root cause | Other |
| Action | On 9/21/04 the firm began visiting customers and replacing the catheter interface cables. |
| Quantity | 3 |
| Distribution | Units were shipped to hospitals, one each in WA, AZ, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042456 | Lysus Infusion System Ekos Corp., Sep 23, 2004 |