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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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