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A Real False Alarm: Johnson & Johnson (JNJ) Recalls Another Product


4/8/2013 8:46:59 AM

As the saying goes: Another day, another Johnson & Johnson recall. The latest involves the 2020 Insulin Infusion Pump sold by the Animas unit for treating diabetes. A "component" issue is causing the device to sound a false alarm and when that happens, the pump may prompt the user to incorrectly follow the usual sequence of steps and lead to an unintended delivery of insulin. This can cause a potentially serious health risk, such as hypoglycemia. As a result, this is being described as a Class I recall, the most serious type that is classified by the FDA.The specific reason is not described any in further detail, but the FDA alert does say the recall affects pumps made between March 1, 2012 and November 30, 2012. We asked J&J for additional information about how many pumps are being recalled and will update you when we hear back. There is another problem, by the way, which is a software limitation that will affect the ability of the pump to function past December 31, 2015. Afterwards, the pump will no linger deliver insulin and will generate a “Call Service Alarm."

Read at PharmaLive

   

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