Recall Z-0993-2013 ยท LZG Pump, Infusion, Insulin
Animas Corporation
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.
| Date | Apr 3, 2013 (initiated Jan 3, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Animas sent an Urgent Recall letter dated December 17, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that Animas will send a replacement pump free of charge, along with instructions for returning their pump. For questions or concerns contact at 866-796-6373. |
| Quantity | 7,157 (494 US pumps affected) |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042873 | ANIMAS MODEL IR1250 INSULIN INFUSION PUMP Animas Corp., Dec 10, 2004 |