Recall Z-0211-05 ยท LZG Pump, Infusion, Insulin
Animas Corporation
IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.
| Date | Nov 19, 2004 (initiated Sep 28, 2004) |
| Status | Terminated |
| Reason | Suspend mode not functioning properly |
| Root cause | Other |
| Action | The recalling firm issued a notice entitled 'Important Safety Information Regarding the Animas IR 1200 Pump' dated 9/28/04 to the health care professionals and distributors. The letter informed the reader of the problem and to use an alternate feature. Health care professionals should notify patients of the problem. |
| Quantity | 7395 units |
| Distribution | The products are shipped to diabetic supply companies in FK, NE, NV, NJ, NY, OH, OK, TX, VA, and WA then further shipped to patients nationwide. The products were shipped to government accounts in IL, MD, and SC. The product was also shipped to a supply company in Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032257 | MODEL IR 1200 INSULIN PUMP Animas Corp., Oct 16, 2003 |