Z-0836-2013 Class III Terminated
FDA device recall Z-0836-2013 was initiated by Animas Corporation on December 17, 2012 and is designated Class III. 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. The recall status is terminated (terminated December 24, 2013). Affected quantity: 37,998.
Recall Details
- Product Type
- Devices
- Report Date
- February 27, 2013
- Initiation Date
- December 17, 2012
- Termination Date
- December 24, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,998
Product Description
Reason for Recall
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.