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.
Recall
- Recall Number
- Z-1892-2008
- Event Number
- 46923
- Firm
- EKOS Corporation
- FEI Number
- 3001627457
- Product Code
- KRA
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- February 20, 2008
- Posted
- September 16, 2008
- Terminated
- May 13, 2011
- Address
- 11911 N Creek Pkwy S, Bothell, WA, 98011-8809
Description
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.
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.
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.
Product was distributed to hospitals in the following states: WA, NC, IL, OH, NY, MI, and KY with no foreign distribution.
10 units