Recall Z-0929-05 ยท LZG Pump, Infusion, Insulin
Animas Corporation
Animas IR 1250 Insulin Pump.
| Date | Jun 25, 2005 (initiated Apr 11, 2005) |
| Status | Terminated |
| Reason | pump failed to respond to keypad button pressess after using the food database feature |
| Root cause | Other |
| Action | The recalling firm issued a recall notice dated 4/11/05 to all patients and healthcare providers via first class mail. The letter instructs the patient to reset the pump, thus correcting any problems caused by the software bug, and to discontinue use of the food database. All distributors were contacted by phone on 4/12/05 and instructed to return all pumps in their inventory. On 4/25/05, the recalling began emailing and telephoning patients to arrange for replacement and return of the devices. |
| Quantity | 2081 units |
| Distribution | The products were shipped to distributors in FL, TX, UT, and VA. The products were also shipped to patients nationwide. |
| 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 |