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. |
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