Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Cor
FDA device recall Z-1773-2008 · posted 2008-08-20 · Terminated
Recall details
- Recalling firm
- EKOS Corporation
- Reason for recall
- Catheter disconnection. There is a potential for the catheter to disconnect from the Catheter Interface Cable (CIC) pod which connects to the Control Unit.
- Action taken
- Firm representatives will visit and distribute connector clips and instructions for use to consignees beginning 04/01/2008 at no cost to the consignee.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 218 units
- Distribution
- Class II Recall - Nationwide
- Date initiated
- 2008-04-01
- Date posted
- 2008-08-20
- Date terminated
- 2011-05-13
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOWAVE INFUSION SYSTEM (K072507) | Ekos Corp. | 2007-10-04 |