Recall Z-0481-2010 ยท MRZ Accessories, Pump, Infusion
Animas Corporation
Animas ezManager Max Diabetes Management System version 2.0.9
| Date | Dec 3, 2009 (initiated Nov 2, 2009) |
| Status | Terminated |
| Reason | Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect. |
| Root cause | Software design |
| Action | Animas issued an Urgent Medical Device Correction letter dated 11/2/09 to the pump user and another letter to the health care professional that prescribed the pump. The letters explain the issue. The patient letter is accompanied with a CD that contains the upgraded software and instructions to follow. |
| Quantity | 20,648 units |
| Distribution | Nationwide distribution, and Canada, Cayman Islands, and Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080587 | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE Animas Corp., May 15, 2008 |