BEUDAMED
    FDA Recall Terminated

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    Recall: Z-0993-2013 · Initiated January 3, 2013

    Recall

    Recall Number
    Z-0993-2013
    Event Number
    64370
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 3, 2013
    Posted
    April 3, 2013
    Terminated
    May 14, 2015
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    Reason

    Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected.

    Action

    Animas sent an Urgent Recall letter dated December 17, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that Animas will send a replacement pump free of charge, along with instructions for returning their pump. For questions or concerns contact at 866-796-6373.

    Distribution

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

    Quantity

    7,157 (494 US pumps affected)