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Deltec Cozmonitor discontinued

Discussion in 'Product Recalls' started by Ellen, Mar 30, 2012.

  1. Ellen

    Ellen Senior Member

    Joined:
    Oct 22, 2005
    Messages:
    8,240
    (no surprise here)
    http://www.smiths-medical.com/Userf...md/cozmore/CoZmonitor FSN.26MAR2012_FINAL.pdf

    MARKET WITHDRAWAL NOTIFICATION
    For CoZmonitor? Blood Glucose Monitoring System
    Affected Devices: CoZmonitor? Blood Glucose Monitoring System,
    Type of Action: Market Withdrawal
    Date: March 27, 2012
    Attention: Distributors, Clinicians, Patients and other Customers
    Details on affected devices: Product Reorder No. 21-1790-01
    Smiths Medical is conducting a voluntary market withdrawal of the CoZmonitor? Blood Glucose
    Monitoring System (?CoZmonitor??). This action is being conducted with the knowledge of the
    relevant Regulatory Agencies.
    The test strips used with the CoZmonitor? are no longer available and no alternative test strips
    are compatible with the CozMonitor?; therefore, when supplies of the FreeStyle? Blood Glucose
    Test Strips (Chemical Composition PQQ) are exhausted, customers must stop using the
    CoZmonitor? and use an alternative Blood Glucose Meter. The CoZmonitor? is not
    compatible for use with any other test strips, including FreeStyle? Blood Glucose Test
    Strips (Chemical Composition FAD).
    Advice on Action to be Taken by the User:
    If you do not use the CoZmonitor?:
    1) If you still have the CoZmonitor?, simply dispose of it in an environmentally safe
    manner, and according to any regulations that may apply; and
    2) Complete and return the attached Confirmation Form (see Attachment 2) by Fax to 1-
    800-237-8033 or by email to cozmonitor@smiths-medical.com.
    If your Deltec Cozmo? pump is still in warranty and you are currently using the CoZmonitor?:
    1) If you currently use the CoZmonitor? and no longer have a supply of FreeStyle? Blood
    Glucose Test Strips (Chemical Composition PQQ), immediately discontinue use of the
    CoZmonitor? and use an alternative method of testing your blood glucose;
    2) If you currently use the CoZmonitor? and have a supply of FreeStyle? Blood Glucose
    Test Strips (Chemical Composition PQQ), with valid expiration dates, you may continue
    using your CozMonitor? while you immediately plan for an alternative method of testing
    your blood glucose;
    3) Contact Smiths Medical Customer Service to discuss alternatives for blood glucose
    testing:
    ? Smiths Medical Customer Service Phone: 1-800-258-5361, prompt #1.
    ? Smiths Medical Customer Service Email: cozmonitor@smiths-medical.com March 27, 2012
    Page 2
    4) Complete and return the attached Confirmation Form (see Attachment 1) by Fax to 1-
    800-237-8033 or by email to cozmonitor@smiths-medical.com; and
    5) Dispose of the CoZmonitor? in an environmentally safe manner, and according to any
    regulations that may apply.
    If you should have any questions regarding this information or how to manually enter your blood
    glucose test results into your Deltec Cozmo? Insulin Pump, please contact Smiths Medical?s
    Clinical Customer Service Department at 1-800-826-9703.
    Smiths Medical is committed to providing quality products and service to its customers. We
    apologize for the inconvenience this situation may have caused.
    Sincerely,
    Tim Giguere
    Manager, Quality Systems
    Smiths Medical ASD, Inc.
    Enclosure: Market Withdrawal Confirmation For
     

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