Recall Z-1773-2008 ยท KRA Catheter, Continuous Flush
EKOS Corporation
Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. Labeled as Sterile, Single Use Only. Connector clip is CIC Connector Clip. The infusion system is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytes, into the peripheral vasculature.
| Date | Aug 20, 2008 (initiated Apr 1, 2008) |
| Status | Terminated |
| Reason | Catheter disconnection. There is a potential for the catheter to disconnect from the Catheter Interface Cable (CIC) pod which connects to the Control Unit. |
| Root cause | Other |
| Action | Firm representatives will visit and distribute connector clips and instructions for use to consignees beginning 04/01/2008 at no cost to the consignee. |
| Quantity | 218 units |
| Distribution | Class II Recall - Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072507 | ENDOWAVE INFUSION SYSTEM Ekos Corp., Oct 4, 2007 |