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U.S. Department of Health and Human Services

Class 2 Device Recall EndoWave Infusion System

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  Class 2 Device Recall EndoWave Infusion System see related information
Date Initiated by Firm February 20, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on May 13, 2011
Recall Number Z-1892-2008
Recall Event ID 46923
510(K)Number K072507  
Product Classification Continuous Flush Catheter - Product Code KRA
Product 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.
Code Information 071126006-001, 071126006-002, 071126006-003, 071126006-005, 071204008-001, 071128015-001, 071128015-002, 071128015-003, 071128015-004, 071128015-005, Item number 500-52106, expiration date 2009-10
Recalling Firm/
Manufacturer		 EKOS Corporation
11911 N Creek Pkwy S
Bothell WA 98011-8809
For Additional Information Contact Jocelyn Kersten
425-415-3132
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 10 units
Distribution Product was distributed to hospitals in the following states: WA, NC, IL, OH, NY, MI, and KY with no foreign distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = EKOS CORP.
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