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Terminated

Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. Labeled as Sterile, Single Use Only. Connector clip is CIC Connector Clip. The infusion system is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytes, into the peripheral vasculature.

FDA Recall Z-1773-2008 · Posted 2008-08-20

Recalling FirmEKOS Corporation
Recall StatusTerminated
Product CodeKRA
Date Initiated2008-04-01
Date Terminated2011-05-13
Product Quantity218 units

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.

Firm Action

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

Distribution Pattern

Class II Recall - Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072507ENDOWAVE INFUSION SYSTEMEkos Corp. · 2007-10-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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