BEUDAMED
    FDA Recall Terminated

    Animas ezManager Max Diabetes Management System version 2.0.9

    Recall: Z-0481-2010 · Initiated November 2, 2009

    Recall

    Recall Number
    Z-0481-2010
    Event Number
    53748
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    MRZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 2, 2009
    Posted
    December 3, 2009
    Terminated
    October 27, 2010
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    Animas ezManager Max Diabetes Management System version 2.0.9

    Reason

    Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.

    Action

    Animas issued an Urgent Medical Device Correction letter dated 11/2/09 to the pump user and another letter to the health care professional that prescribed the pump. The letters explain the issue. The patient letter is accompanied with a CD that contains the upgraded software and instructions to follow.

    Distribution

    Nationwide distribution, and Canada, Cayman Islands, and Denmark.

    Quantity

    20,648 units