BEUDAMED
    FDA Recall Terminated

    NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

    Recall: Z-0864-2013 · Initiated January 11, 2013

    Recall

    Recall Number
    Z-0864-2013
    Event Number
    64158
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 11, 2013
    Posted
    February 20, 2013
    Terminated
    August 10, 2015
    Address
    325 Paramount Drive, Raynham, MA, 02767

    Description

    NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 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

    Action

    Codman sent an Urgent Voluntary Product Recall Notification letter dated January 11, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to check all inventory to determine if they have any affected product, use the included instructions to report inventory status, return and obtain replacement product. Customers were instructed to contact your local Codman Representative or Stericycle at 1-866-201-9077. For questions regarding this recall call 508-880-8100.

    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

    25