BEUDAMED
    FDA Recall Terminated

    Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.

    Recall: Z-1264-2009 · Initiated March 16, 2009

    Recall

    Recall Number
    Z-1264-2009
    Event Number
    51438
    Firm
    Spectranetics Corporation
    FEI Number
    3007284006
    Product Code
    OEX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 16, 2009
    Posted
    June 1, 2009
    Terminated
    November 28, 2011
    Address
    9965 Federal Dr, Colorado Springs, CO, 80921-3617

    Description

    Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.

    Reason

    Catheter outer jacket may split during use.

    Action

    Spectranetics notified the 8 recipients of the catheters by letter on 3/17/2009. They were told that a Spectranetics sales rep would contact them to coordinate the return of the suspect devices. Questions were referred to 719-447-2462 or 719-447-2539.

    Distribution

    Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA.

    Quantity

    17 units