BEUDAMED
    FDA Recall Terminated

    Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado Springs, Colorado 80907. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

    Recall: Z-0903-2009 · Initiated October 15, 2008

    Recall

    Recall Number
    Z-0903-2009
    Event Number
    50512
    Firm
    Spectranetics Corporation
    FEI Number
    3007284006
    Product Code
    OEX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 15, 2008
    Posted
    January 30, 2009
    Terminated
    February 26, 2009
    Address
    96 Talamine Ct, Colorado Springs, CO, 80907

    Description

    Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado Springs, Colorado 80907. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

    Reason

    Catheter pouch was mislabeled with the wrong size.

    Action

    Consignees were notified by sales representatives who visually inspected their inventory. The sales representatives were given a form to fill out to confirm whether the consignee had the catheters with the serial number still in inventory. The forms were faxed back to Spectranetics indicating if the catheters were used or not and if they were not used, were they labeled correctly. For assistance, contact Spectranetics Corporation at 1-719-447-2319.

    Distribution

    CA, FL, MI, NC, NY, OH, PA, TX, and VA.

    Quantity

    24 units