BEUDAMED
    FDA Recall Terminated

    Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE EO***Cordis Europa N.V., 9301 LJ Roden, The Netherlands***''

    Recall: Z-1556-05 · Initiated May 11, 2005

    Recall

    Recall Number
    Z-1556-05
    Event Number
    32576
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    LIT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 11, 2005
    Posted
    September 21, 2005
    Terminated
    November 20, 2008
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE EO***Cordis Europa N.V., 9301 LJ Roden, The Netherlands***''

    Reason

    During competitive product testing, wire movement difficulties were observed in Powerflex P3 units. Due to the possibility of user inconvenience, Cordis is recalling the six affected lots of Powerflex P3. There is no patient impact.

    Action

    Recalled by letter and Cordis Sales Representatives interfacing directly with US consignees.

    Distribution

    Distributed to 35 consignees throughout the US and other consignees in 11 countries worldwide.

    Quantity

    48 units