Animas 2020 Insulin Infusion Pump

Starting date:

January 3, 2013

Posting date:

February 4, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-17229

• Reason
• Affected products

Recalled Products

1. Animas 2020 Insulin Infusion Pump

Reason

A small number of Animas 2020 Insulin Infusion Pumps are potentially affected by a misalignment of a component on the printed circuit board assembly. This component misalignment results in the Insulin Pump potentially measuring force conditions incorrectly, resulting in false warnings and/or alarms. Should the patient complete a load sequence or prime the insulin infusion pump and does not disconnect from the infusion set from the body, the insulin infusion pump may dispense all of the insulin in the cartridge into the patient. There is no safety risk as long as the patient follows the instructions for use and always disconnects the infusion set prior to priming the pump, changing the cartridge, and rewinding the motor.

Affected products