BEUDAMED
    FDA Recall Terminated

    Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.

    Recall: Z-2190-2010 · Initiated July 1, 2010

    Recall

    Recall Number
    Z-2190-2010
    Event Number
    56115
    Firm
    Spectranetics Corporation
    FEI Number
    3007284006
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 1, 2010
    Posted
    August 9, 2010
    Terminated
    August 20, 2010
    Address
    96 Talamine Ct, Colorado Springs, CO, 80907-5159

    Description

    Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.

    Reason

    Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.

    Action

    Consignees were notified by letter on Jul 1, 2010, and told to not use affected lots and to contact Spectranetics to arrange a product exchange. More information is available at 800-231-0978.

    Distribution

    Worldwide distribution: USA, Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela.

    Quantity

    5080 units (1778 US, 3302 Non-US)