Amigo Insulin Infusion Pump
FDA device recall Z-1335-04 · posted 2004-09-14 · Terminated
Recall details
- Recalling firm
- Nipro Diabetes Systems, Inc.
- Reason for recall
- A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation.
- Action taken
- The firm will notify each distributor and user by letter and/or telephone of the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 8 Pumps
- Distribution
- Distributed to New York, New Jersey, Florida,Indiana, Utah, Colorado and Wyoming.
- Date initiated
- 2004-05-07
- Date posted
- 2004-09-14
- Date terminated
- 2012-05-03
- Location
- Miramar, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GLUCOPRO EVO INFUSION PUMP (K013309) | Nipro Diabetes Systems, Inc. | 2002-06-24 |