Smiths Medical initiates voluntary market withdrawal of CoZmonitor Blood Glucose Monitoring Systems

Smiths Medical, a leading global medical device manufacturer, announced today that it is initiating a U.S. and Canada, voluntary market withdrawal of CoZmonitor® Blood Glucose Monitoring Systems. The FDA has been apprised of this action.

Smiths Medical is conducting this voluntary market withdrawal because the test strips used with the CoZmonitor® are no longer available and no alternative test strips are compatible with the CoZmonitor®. Customers using the CoZmonitor® should seek an alternative Blood Glucose Meter.

A copy of the customer notification letter is posted on the Smiths Medical website at http://www.smiths-medical.com/Userfiles/landing-pages/promotions/md/cozmore/CoZmonitor%20FSN.26MAR2012_FINAL.pdf

and at the CozMore website at http://www.smiths-medical.com/landing-pages/promotions/md/coz-home.html.

Consumers should do the following:

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.

2) Complete the Confirmation Form located at http://www.smiths-medical.com and return it by Fax to 1-800-237-8033 or by email to [email protected]

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 alternative options for blood glucose testing:

  • Smiths Medical Customer Service Phone: 1-800-258-5361, prompt #1
  • Smiths Medical Customer Service Email: [email protected]

4) Complete the Confirmation Form located at http://www.smiths-medical.com and return it by Fax to 1-800-237-8033 or by email to [email protected]; 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.

Details of Affected Devices:
CoZmonitor® Blood Glucose Monitoring System
Product Reorder No. 21-1790-01

Smiths Medical is notifying its customers through the UPS delivery.

Source:

 Smiths Medical

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