| | Class 3 Recall
Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps |  |
| Date Posted |
February 17, 2013 |
| Recall Number |
Z-0836-2013 |
| Product |
Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps
Indicated for continuous subcutaneous infusion of insulin. |
| 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.
|
Recalling Firm/
Manufacturer |
Animas Corporation
200 Lawrence Dr
West Chester, Pennsylvania 19380-3428 |
| Consumer Instructions |
No consumer action necessary |
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.
|
| 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. |
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