BEUDAMED
    FDA Recall Terminated

    Disetronic D-TRONplus Insulin Pump

    Recall: Z-1198-03 · Initiated July 24, 2003

    Recall

    Recall Number
    Z-1198-03
    Event Number
    26825
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 24, 2003
    Posted
    September 23, 2003
    Terminated
    March 10, 2009
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Disetronic D-TRONplus Insulin Pump

    Reason

    Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.

    Action

    An urgent product correction and removal letter dated 7/24/03 was issued to each pump user informing of potential problems with the pump and instructing them how to proceed if they wish to discontinue use of the pump, have it replaced, or have questions regarding the pump.

    Distribution

    United States

    Quantity

    8000