BEUDAMED
    FDA Enforcement Class II Terminated

    NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

    Recall: Z-0858-2013 · Reported February 27, 2013

    Enforcement

    Recall Number
    Z-0858-2013
    Event ID
    64158
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Codman & Shurtleff, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2013
    Initiation Date
    January 11, 2013
    Classification Date
    February 20, 2013
    Termination Date
    August 10, 2015
    Address
    325 Paramount Drive, N/A, Raynham, MA, 02767, United States

    Description

    NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

    Reason

    Sterility of device may be compromised due to lack of package integrity

    Code Info

    All unexpired lots

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.

    Quantity

    46 units