Recall Z-0307-06 ยท LZG Pump, Infusion, Insulin
Animas Corporation
Isulin Pump. Model IR1000
| Date | Dec 23, 2005 (initiated Oct 31, 2005) |
| Status | Terminated |
| Reason | Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure. |
| Root cause | Other |
| Action | The recalling firm telephoned the users on 10/31/05 to inform them of the problem and that the pump would be replaced if the user choose to return it. |
| Quantity | 6 units |
| Distribution | The pumps were shipped to patients CA, CO, FL, IL, KS, MA, MI, NJ, NY, NC, NV, PA,TN, TX, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021439 | MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO Animas Corp., May 29, 2002 |