BEUDAMED
    FDA Recall Terminated

    Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.

    Recall: Z-2952-2011 · Initiated July 18, 2011

    Recall

    Recall Number
    Z-2952-2011
    Event Number
    59382
    Firm
    Spectranetics Corporation
    FEI Number
    3007284006
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 18, 2011
    Posted
    August 4, 2011
    Terminated
    August 12, 2011
    Address
    96 Talamine Ct, Colorado Springs, CO, 80907-5159

    Description

    Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.

    Reason

    Packaging integrity may be compromised, thus sterility can not be assured.

    Action

    Spectranetics sent an "PRODUCT RECALL NOTICE: EU SHIPMENTS OF TURBO-BOOSTER LASER GUIDE CATHETERS" letter dated July 15, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and set aside affected product. Customers are to contact their sales representative for information on how to return the affected product and receive replacement product. Further information is available at +011.49.719.447.2539.

    Distribution

    Foreign Distribution-including the countries of Belgium, Cyprus, Germany, Greece, Italy, Spain, Switzerland, and United Kingdom.

    Quantity

    123 units