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LAWSUITS NEWS & LEGAL INFORMATION

FDA Recalls Battery Caps for Animas Insulin Devices


Potential Risk for Devices to Stop Administering Insulin

Animas Corporation and the FDA have issued a nationwide recall of battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump.

The battery caps used with the above infusion pumps were manufactured from June 1, 2008 through July 31, 2008, and were distributed from June 16, 2008 through August 1, 2008.

There is a risk of intermittent loss of contact between the battery cap and the battery compartment in the pump. This may result in the device resetting, and possibly cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia).

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Published on Nov-21-08


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