The Recall Desk
HighFDA (Devices)·Z-0836-2013·Announced 2013-02-27

Animas Insulin Pumps Cease Operation Due to Calendar Date Limit

Animas Corporation is recalling insulin infusion pumps that will stop operating on January 1, 2016, due to an internal calendar date limit.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device for insulin infusion that will cease to operate, creating a risk of harm to patients who rely on continuous insulin delivery, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Animas Corporation is recalling the Animas 2020, Animas IR 1250 (1200 plus), and Animas IR 1200 insulin infusion pumps. These devices are indicated for the continuous subcutaneous infusion of insulin. The recall involves 37,998 units distributed worldwide, including the United States, Puerto Rico, US Virgin Islands, and various international countries.

The recall is necessary because the pumps contain an internal calendar date limit set for December 31, 2015. As a result, the devices will cease to operate on January 1, 2016. When this occurs, the pumps will display a call service alarm on the screen.

Consumers using these specific pump models should contact Animas Corporation for instructions on how to proceed. The affected part numbers include 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, 100385-00, 100450-00, 100210-00, 100211-00, 100212-00, 100250-00, 100251-00, 100252-00, 100200-00, 100201-00, 100202-00, 100170-00, 100171-00, and 100172-00.

The recalled product

Product
Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.
Manufacturer
Animas Corporation
Category
Medical Device — Insulin Infusion Pump
Hazard
Affected units
37,998

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • All Animas 2020
  • IR1250 and IR1200 Pump Models - Part Numbers 101370-00
  • 101371-00
  • 101372-00
  • 101374-00
  • 101375-00
  • 100380-00
  • 100381-00
  • 100382-00
  • 100384-00
  • 100385-00
  • 100450-00
  • 100210-00
  • 100211-00
  • 100212-00
  • 100250-00
  • 100251-00
  • 100252-00
  • 100200-00
  • 100201-00

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

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