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Class I Medical Device Recall: Animas Corporation 2020 Insulin Infusion Pump

Fri, 04/05/2013 - 12:00am
U.S. Food & Drug Administration

Recall Class:  Class I

Date Recall Initiated: January 3, 2013

Product(s):

  • Animas 2020 Insulin Infusion Pumps

Lot numbers: All lots manufactured from March 1, 2012 to November 30, 2012.

Manufacturing and Distribution Dates: The affected products were manufactured from March 1, 2012 to November 30, 2012 and distributed from March 1, 2012 to September 30, 2012.

Use:
The Animas 2020 Insulin Pumps are used to deliver insulin directly into your blood for the treatment of diabetes.

Recalling Firm:
Animas Corporation
200 Lawrence Dr.
West Chester, PA 19380-3428

Reason for Recall:
Animas has identified a component issue affecting Animas(R) 2020 Infusion Insulin
Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following:

  • “Loss of prime”
  • “Occlusion”
  • “No Cartridge detected”

If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect your infusion set from your body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia.

Users should follow the safety instructions in your Animas Owner’s Booklet and ALWAYS disconnect the infusion set from your body when:

  • Rewinding the motor
  • Loading the cartridge
  • Priming the infusion set

The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no linger deliver insulin and will generate a “Call Service Alarm.”

This product may cause serious adverse health consequences, including death. 

Public Contact: Customers with the device should contact Animas’ Product Fulfillment Center at 877-280-2339 between the hours of 6 a.m. and 12 a.m. EST to schedule shipment of your free replacement pump. Customers with technical questions or who want to report a concern should contact Customer Technical Support Center at 866-793-5253.

FDA District: Philadelphia District Office

FDA Comments: 
Customers who have purchased the affected devices were notified by letter dated January 3, 2013 about the problem. The letter included instructions for customers to contact Animas’ Product Fulfillment Center to schedule shipment of their free replacement pump at 1-877-280-2339 between the hours of 6 a.m. and 12 a.m. Eastern Standard Time.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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