BEUDAMED
    FDA Recall Terminated

    Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.

    Recall: Z-0836-2013 · Initiated December 17, 2012

    Recall

    Recall Number
    Z-0836-2013
    Event Number
    64307
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 17, 2012
    Posted
    February 17, 2013
    Terminated
    December 24, 2013
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.

    Reason

    Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display.

    Action

    The firm initiated their recall of this product on December 17, 2012 by sending a letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Animas Customer Support Department at (866) 796-6373 for questions or concerns.

    Distribution

    Worldwide Distribution-USA (nationwide) including Washington, DC, Puerto Rico, US Virgin Island and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Austria, Australia, Bermuda, Canada, New Zealand, Czech Republic, Italy, France, Finland, Hungary, Israel, United Kingdom, Spain, Sweden, Norway, Denmark, Germany, Mexico and Ireland.

    Quantity

    37,998