BEUDAMED
    FDA Recall Terminated

    Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.

    Recall: Z-1482-06 · Initiated August 11, 2006

    Recall

    Recall Number
    Z-1482-06
    Event Number
    36077
    Firm
    Cordis Neurovascular, Inc.
    FEI Number
    1000222137
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 11, 2006
    Posted
    September 2, 2006
    Terminated
    November 25, 2008
    Address
    14200 NW 57th Ct, Miami Lakes, FL, 33014-3105

    Description

    Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.

    Reason

    Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch.

    Action

    All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication.

    Distribution

    Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada, Japan and Australia.

    Quantity

    15 Lot numbers (46,452)