BEUDAMED
    FDA Recall Terminated

    OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

    Recall: Z-1376-2012 · Initiated March 1, 2012

    Recall

    Recall Number
    Z-1376-2012
    Event Number
    61436
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 1, 2012
    Posted
    April 6, 2012
    Terminated
    December 24, 2013
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

    Reason

    There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt to change the time or date on their pump on February 29, 2012 are not affected by this issue.

    Action

    The firm initiated their recall on March 1, 2012 and sent Urgent Notification letters dated March 6, 2012 to all consignees by UPS with delivery confirmation. Customers were notified of the issue and the appropriate steps to take in order to mitigate the issue. A Web Letter for users was also posted to the Animas web site. Questions were directed to (855) 230-7577.

    Distribution

    Worldwide Distribution, (USA) including the states of AK, AL, AR, AZ, CA, CO, CT, DC, 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, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada and the territory of Puerto Rico.

    Quantity

    91,239