Recall Z-1335-04 ยท LZG Pump, Infusion, Insulin
Nipro Diabetes Systems, Inc.
Amigo Insulin Infusion Pump
| Date | Sep 14, 2004 (initiated May 7, 2004) |
| Status | Terminated |
| Reason | A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation. |
| Root cause | Other |
| Action | The firm will notify each distributor and user by letter and/or telephone of the recall. |
| Quantity | 8 Pumps |
| Distribution | Distributed to New York, New Jersey, Florida,Indiana, Utah, Colorado and Wyoming. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013309 | GLUCOPRO EVO INFUSION PUMP Nipro Diabetes Systems, Inc., Jun 24, 2002 |