Recall Z-0005-2013 ยท LZG Pump, Infusion, Insulin
Animas Corporation
IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
| Date | Oct 2, 2012 (initiated Jul 16, 2012) |
| Status | Terminated |
| Reason | Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Animas Corporation, sent an "IMPORTANT PATIENT NOTIFICATION" letter dated July 16, 2012 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to examine their insulin pump for wear or damage on a regular basis, as part of their routine process of inspecting their pump. If keypad is worn or damaged, the buttons may not respond as intended. If consignees/customers see any damage or have issues with the keypad, they are to contact Animas through their website at www.animas.com/contact-animas or teleph |
| Quantity | 236,470 |
| Distribution | Worldwide distribution: USA (nationwide) including 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, V, VT, WA, WI, WV, WY and Washington, DC and countries of: Au |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032257 | MODEL IR 1200 INSULIN PUMP Animas Corp., Oct 16, 2003 |