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Animas Corporation recalls Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion o
Recalled April 10, 2013 · FDA recall Z-0993-2013 · Animas
Hazard
Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected. · FDA Class I
Units
7,157 (494 US pumps affected)
Sold at
Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico and the countries of: Australia, Austria, Bermuda, Canada, Czech Republic, Finland, France, Germany, Ireland, Israel, Italy, Mexico, New Zealand, Norway, Spain and the United Kingdom.
Description
Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected.
Product
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Manufacturer(s)
Animas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →