Recall Z-1892-2008 ยท KRA Catheter, Continuous Flush
EKOS Corporation
EKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound Core. Labeled as Sterile, Single Use Only. The device is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
| Date | Sep 16, 2008 (initiated Feb 20, 2008) |
| Status | Terminated |
| Reason | Product mislabeled - 6 cm treatment zone catheter had been built using 50 cm treatment zone drilled tubing. Consequently, drug was delivered outside of the treatment zone. |
| Root cause | Process control |
| Action | On 02/20/08 firm notified customers by phone or email informing them of the issue and notifying them to segregate affected product and hold for return. Letters were sent via FedEx or email, or were hand delivered by firm representative to customers on 02/21/08 informing them of the issue and requesting return of affected product for replacement. Contact Jocelyn Kersten at 425-415-3132 if you have questions. |
| Quantity | 10 units |
| Distribution | Product was distributed to hospitals in the following states: WA, NC, IL, OH, NY, MI, and KY with no foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072507 | ENDOWAVE INFUSION SYSTEM Ekos Corp., Oct 4, 2007 |