BEUDAMED
    FDA Recall Terminated

    Battery Caps used with Animas IR1250 Insulin Pump. The pump is used to help maintain blood glucose targets.

    Recall: Z-0294-2009 · Initiated August 4, 2008

    Recall

    Recall Number
    Z-0294-2009
    Event Number
    49476
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 4, 2008
    Posted
    November 25, 2008
    Terminated
    February 4, 2010
    Address
    200 Lawrence Dr, West Chester, PA, 19380

    Description

    Battery Caps used with Animas IR1250 Insulin Pump. The pump is used to help maintain blood glucose targets.

    Reason

    Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.

    Action

    The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions.

    Distribution

    Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.

    Quantity

    1,624 units