BEUDAMED
    FDA Recall Terminated

    Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.

    Recall: Z-0698-2008 · Initiated December 10, 2007

    Recall

    Recall Number
    Z-0698-2008
    Event Number
    45949
    Firm
    Spectranetics Corporation
    FEI Number
    3007284006
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 10, 2007
    Posted
    February 5, 2008
    Terminated
    February 8, 2008
    Address
    96 Talamine Ct, Colorado Springs, CO, 80907-5159

    Description

    Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.

    Reason

    Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.

    Action

    Consignees were notified by Dear Healthcare provider letter on 12/10/2007 and were told that a sales rep would remove and replace all affected catheters.

    Distribution

    Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT.

    Quantity

    64