Z-0836-2013Class III

Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for...

Name: Z-0836-2013 Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for...
Creator: Animas Corporation
Published: 2012-12-17
License: https://open.fda.gov/license/

Animas Corp. / initiated 2012-12-17 / Terminated / root cause: design

FDA source

Animas Corporation began a recall of Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin on 2012-12-17. FDA classified it as Class III and gives the reason as "Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0836-2013
Classification: Class III
Status: Terminated
Initiated: 2012-12-17
Posted: 2013-02-17
Terminated: 2013-12-24
Recalling firm: Animas Corp.
Product: Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display.
Root cause tag: design
FDA root cause: Device Design
Action: The firm initiated their recall of this product on December 17, 2012 by sending a letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Animas Customer Support Department at (866) 796-6373 for questions or concerns.
Quantity in commerce: 37,998
Distribution: Worldwide Distribution-USA (nationwide) including Washington, DC, Puerto Rico, US Virgin Island and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Austria, Australia, Bermuda, Canada, New Zealand, Czech Republic, Italy, France, Finland, Hungary, Israel, United Kingdom, Spain, Sweden, Norway, Denmark, Germany, Mexico and Ireland.
Product codes and lots: 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, 100202-00, 100170-00, 100171-00 and 100172-00.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0836-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0836-2013	Class III	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-17

Product code LZG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)