EKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound Core. Labeled as Sterile, Single
FDA device recall Z-1892-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- EKOS Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 10 units
- Distribution
- Product was distributed to hospitals in the following states: WA, NC, IL, OH, NY, MI, and KY with no foreign distribution.
- Date initiated
- 2008-02-20
- Date posted
- 2008-09-16
- 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 |