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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Product Detail

Product Description Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.
Recall Number Z-0836-2013
Classification Class III
Code Info 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.
Product Distributed Qty 37,998
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.

Event Detail

Event Id 64307
Product Type Devices
Status Ongoing
Recalling Firm Animas Corporation
City West Chester
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-17
Initial Firm Notification of Consignee or Public Letter
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.