BEUDAMED
    FDA Recall Terminated

    CORDIS "Fire Star" 2.25 x 10 Dilatation Catheter, Catalog # 80110225, Distributed by Cordis Corporation, Miami Lakes, FL 33014

    Recall: Z-0791-2008 · Initiated January 14, 2008

    Recall

    Recall Number
    Z-0791-2008
    Event Number
    46378
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    LOX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 14, 2008
    Posted
    February 6, 2008
    Terminated
    October 20, 2009
    Address
    14201 NW 60th Avenue, Miami Lakes, FL, 33014-2802

    Description

    CORDIS "Fire Star" 2.25 x 10 Dilatation Catheter, Catalog # 80110225, Distributed by Cordis Corporation, Miami Lakes, FL 33014

    Reason

    Slow Deflation or No Deflation

    Action

    Cordis initated the recall on 1/14/2008. For U.S. customers: An Urgent Medical Device Recall letter and an Acknowledgement Form was sent to the following 4 individuals in each account: Cath Lab Director, Operating Room Director, Materials Director, Risk Manager; to be followed up with direct Cordis representative contact to facilitate obtaining signature, faxing form, collecting and returning units. For non-US customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries. All users were instructed to immediately set aside product and return it for replacement.

    Distribution

    Worldwide.

    Quantity

    133,300 units total for recalls Z-0747-0824-2008