BEUDAMED
    FDA Recall Terminated

    DANA Diabecare II insulin pumps

    Recall: Z-1451-04 · Initiated May 26, 2004

    Recall

    Recall Number
    Z-1451-04
    Event Number
    29472
    Firm
    Dana Diabecare USA LLC
    FEI Number
    3003432903
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 26, 2004
    Posted
    September 14, 2004
    Terminated
    December 10, 2004
    Address
    541 Julia Street, Floor 3rd, New Orleans, LA, 70130

    Description

    DANA Diabecare II insulin pumps

    Reason

    There is a switch malfunction that that may cause the unit not to respond when command key is depressed.

    Action

    An email was sent to the sales representatives requesting the return of the pumps. The patients were contacted by telephone and letters requesting the return of the pumps.

    Distribution

    AZ, WV, PA, FL, WI, MI, TN, MD