BEUDAMED
    FDA Recall Terminated

    Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    Recall: Z-0137-2015 · Initiated October 25, 2012

    Recall

    Recall Number
    Z-0137-2015
    Event Number
    69296
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 25, 2012
    Posted
    October 24, 2014
    Terminated
    June 29, 2015
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    Reason

    Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.

    Action

    Animas initiated the notification to Distributors by letter, dated July 2012, and Patients and Health Care Professionals were notified by letter in September 2012. The delay in notifying patients and health care professionals was driven by the need to have sufficient inventory of replacement product on hand in order to meet anticipated demand before sending the letters.

    Distribution

    Worldwide Distribution in the countries of France, Italy, Sweden, and UK..

    Quantity

    1938