Recall Z-1560-2010 ยท LZG Pump, Infusion, Insulin
Animas Corporation
One Touch Ping Insulin Pump using ezManager Max diabetes management software
| Date | May 8, 2010 (initiated Dec 18, 2009) |
| Status | Terminated |
| Reason | Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food database and pump settings using the software. |
| Root cause | Software design |
| Action | The recalling firm telephoned the patients/users to inform them of the problem. A letter dated 12/22/09 was also sent to users. Users will have a replacement unit sent to them so that they will be able to fully utilize the pump and the software. As a courtesy a letter dated 12/22/09 was issued to the health care provider/prescribing physician for the affected users. |
| Quantity | 21 pumps |
| Distribution | The pumps were provided to patients/users in CA, CT, FL, GA, ID, MA, MO, NJ, OH, OR, PA, TX, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080639 | SYMPHONY GLUCOSE MANAGEMENT SYSTEM Animas Corp., Jun 24, 2008 |