WASHINGTON -- The FDA has issued a class I recall for the Animas 2020 insulin infusion pump due to false alarms that may trigger, cease device function, and cause serious adverse events.

All lots of the pump manufactured from March 1, 2012 to Nov. 30, 2012 may contain a malfunctioning component that can trigger a false alarm or warning, which requires the user to "complete the rewind, load, and prime sequence to clear this alarm," according to the agency.

Patients who do not disconnect the pump from their body before undertaking these steps risk an unintended delivery of insulin, which can lead to hypoglycemia or other serious adverse events and death, the FDA stated.

The false warnings indicate "loss of prime," "occlusion," or "no cartridge detected" and may require the user to rewind the motor, load the cartridge, and prime the infusion set to clear the alarm.

The pump also has a software malfunction that will prevent it from working past Dec. 31, 2015.

The device recall was initiated on Jan. 3, 2013, when Animas notified its customers who purchased the pump about the problem and offered a free replacement.

Class I recalls affect devices with a reasonable risk of serious adverse events or death with use.