BEUDAMED
    FDA Recall Terminated

    Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior.

    Recall: Z-0798-03 · Initiated March 14, 2003

    Recall

    Recall Number
    Z-0798-03
    Event Number
    25780
    Firm
    Deltec, Inc
    FEI Number
    2183502
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 14, 2003
    Posted
    May 9, 2003
    Terminated
    July 2, 2004
    Address
    1265 Grey Fox Road, St Paul, MN, 55112

    Description

    Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior.

    Reason

    A software error could have resulted in the delivery of a larger bolus of insulin than anticipated when the pump was programmed in a particular manner.

    Action

    Recall Notification letters were sent to the consignees on March 14, 2003. The letters gave recommendations for avoiding the problem, stated that updated software to prevent the problem would be introduced, and requested that the customer call a toll-free phone number to arrange replacement of their affected pump.

    Distribution

    The product was distributed nationwide in the United States. There are no foreign or U.S. Government accounts.

    Quantity

    913 pumps