BEUDAMED
    FDA Recall 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.

    Recall: Z-1773-2008 · Initiated April 1, 2008

    Recall

    Recall Number
    Z-1773-2008
    Event Number
    47785
    Firm
    EKOS Corporation
    FEI Number
    3001627457
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 1, 2008
    Posted
    August 20, 2008
    Terminated
    May 13, 2011
    Address
    11911 N Creek Pkwy S, Bothell, WA, 98011-8809

    Description

    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.

    Reason

    Catheter disconnection. There is a potential for the catheter to disconnect from the Catheter Interface Cable (CIC) pod which connects to the Control Unit.

    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.

    Distribution

    Class II Recall - Nationwide

    Quantity

    218 units