FDA recalls defective medical device Animas Infusion Insulin pump

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The Food and Drug Administration (FDA) has issued a new Class I recall involving a defective medical device.  The Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012 are the recalled devices. The insulin pumps are used in the treatment of diabetes to deliver insulin directly into the user’s body. According to the FDA, a component in the recalled pumps may trigger the pumps to sound a false alarm related to “loss of prime, occlusion or no cartridge detected.”

If the consumer receives any of these alarms, the insulin pump may prompt the consumer to rewind, load, and prime the pump to clear the alarm. Failure to follow the pump’s instructions and failure to disconnect the pump from the body before the “rewind, load and prime” steps are initiated, can result in an unintended dose of insulin being delivered, with potentially serious health consequences, including hypoglycemia.

This latest defective medical device recall is a “Class I” recall, which is the most serious type of initiated by the FDA. Class I recalls are issued when there is a threat of serious injury or death.

For more information, contact the Ohio defective medical device lawyers at Clark, Perdue & List

Source: FDA MedWatch Safety Alert, “Animas Corporation 2020 Insulin Infusion Pump: Class I Recall – False Alarm or Warning Sound,” April 5, 2013.