BEUDAMED
    FDA Recall Terminated

    IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

    Recall: Z-0005-2013 · Initiated July 16, 2012

    Recall

    Recall Number
    Z-0005-2013
    Event Number
    61780
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 16, 2012
    Posted
    October 2, 2012
    Terminated
    January 15, 2014
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

    Reason

    Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump.

    Action

    The firm, Animas Corporation, sent an "IMPORTANT PATIENT NOTIFICATION" letter dated July 16, 2012 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to examine their insulin pump for wear or damage on a regular basis, as part of their routine process of inspecting their pump. If keypad is worn or damaged, the buttons may not respond as intended. If consignees/customers see any damage or have issues with the keypad, they are to contact Animas through their website at www.animas.com/contact-animas or telephone Animas Customer Technical Support at 1-855-230-7574, or the phone number provided on the back of their insulin pump. Animas carefully investigates all complaints related to the insulin pump keypad. If you have any questions contact Animas Customer Technical Support at 1-855-230-7574.

    Distribution

    Worldwide distribution: USA (nationwide) including 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, V, VT, WA, WI, WV, WY and Washington, DC and countries of: Austria, Australia, Canada, Czech Republic, France, Finland, Germany, Hungary, Israel, Italy, Mexico, New Zealand, Puerto Rico, Spain, and United Kingdom.

    Quantity

    236,470