Amigo Insulin Infusion Pump
- Company
- Nipro Diabetes Systems, Inc.
- Recall Initiated
- May 7, 2004
- Posted
- September 14, 2004
- Terminated
- May 3, 2012
- Recall Number
- Z-1335-04
- Quantity
- 8 Pumps
- Firm Location
- Miramar, FL
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.
Distribution
Distributed to New York, New Jersey, Florida,Indiana, Utah, Colorado and Wyoming.
Lot / Code Info
Model #s 990001, 990002, 990003, 990004, 990005 and 990006. all associated codes, all units distributed have been recalled.
Root Cause
Other
Action Taken
The firm will notify each distributor and user by letter and/or telephone of the recall.