BEUDAMED
    FDA Recall Terminated

    Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49

    Recall: Z-1623-2008 · Initiated March 10, 2008

    Recall

    Recall Number
    Z-1623-2008
    Event Number
    47753
    Firm
    Smiths Medical MD, Inc.
    FEI Number
    2183502
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    March 10, 2008
    Posted
    August 15, 2008
    Terminated
    January 13, 2011
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49

    Reason

    Smith Medical discovered an issue with a motor component in specific serial numbers of the Deltec Cozmo Insulin Pump, Model Numbers 1700 and 1800. This issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.

    Action

    Consignees were mailed an Urgent Medical Device Recall letter dated March 10, 2008. The Urgent letter addressed to "Distributors, Clinicans, Patients and Other Customers" contains Description of the Problem, Results of Investigation, and Advise on Action to be taken by the User. The patient users will be required to return a Recall Confrirmation Form. The USA distributors, USA prescribing physicians and the USA managed Care Accounts (Insurance Companies) will be mailed also a cover letter.

    Distribution

    Class II Recall - Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME. RO, MN, MO, MS, ME, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of Greece, Netherland, Sweden, France, Germany, Turkey, China, Great Britain, Israel, Italy, Kuwait, New Zealand, Australia.

    Quantity

    1066