Press release from Animas
April 08, 2013
The U.S. Food and Drug Administration (FDA) has classified Animas Corporation’s January 2013 field action related to Animas® 2020 Insulin Pump as a Class I recall.
The voluntary recall, initiated on January 3, 2013, involves only a small supply of our Animas® 2020 insulin pumps manufactured between March and November 2012. Affected patients were notified in early January and were provided with a replacement pump. Animas recently discontinued the Animas® 2020 insulin pump in North America, and therefore replaced the 2020 pumps in the hands of patients with a OneTouch® Ping®Glucose Management System, which includes an insulin pump and a glucose meter that can also act as a remote controller of the pump.
Animas initiated the voluntary worldwide recall due to a component issue impacting a small supply of our Animas® 2020 insulin pumps. In certain pumps, the component issue may have resulted in triggering a pump to sound a false alarm or warning related to one of the following: “Loss of prime,” “Occlusion” or “No Cartridge detected.” Patients are not at any risk from this component issue as long as they follow the safety instructions in the Animas Owner’s Booklet and always disconnect the infusion set from the body when rewinding the motor, loading the cartridge or priming the infusion set.
Animas informed FDA about this recall in December 2012 before beginning the process of notifying patients, healthcare professionals, distributors and our partners of the recall by official letter beginning January 3, 2013. The initial letter included detailed recall instructions and was posted on our Web site athttp://www.animas.com/product-safety. Regulatory authorities worldwide also have been informed.
If healthcare professionals or patients have any additional questions about the Animas® 2020 Insulin Pump recall, they may call our Customer Technical Support Center at 866‐793‐5253.