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Recall Observatory FDA recall evidence

Device product

Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.

Z-0836-2013

December 17, 2012

Class III

Product summary

Firm
Animas Corporation
Event
Event 64307
Status
Terminated
Classification
Class III
Quantity
37,998
Official record key
device-enforcement:Z-0836-2013

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.