BEUDAMED
    FDA Recall Terminated

    Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.

    Recall: Z-3017-2011 · Initiated July 29, 2011

    Recall

    Recall Number
    Z-3017-2011
    Event Number
    59517
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 29, 2011
    Posted
    August 12, 2011
    Terminated
    December 7, 2011
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.

    Reason

    Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not related to the condition of the battery.

    Action

    Animas Corporation sent an "Urgent: Insulin Pump Recall" letter dated July, 29 20011 to all affected customers. The letter included affected product and problem. They requested anyone who received the pump to send it back to Animas and a replacement pump will be sent at no charge. For additional information contact the Customer Support Department at (877) 937-7867.

    Distribution

    Worldwide Distribution: Nationwide (USA) distribution including the states of CA, CO, MA, and MD; and the countries of Australia, Finland, France, Israel, Italy, Sweden and the U.K.

    Quantity

    380