FDA Medical Device Recalls (openFDA)
Nipro Diabetes Systems, Inc.: Amigo Insulin Infusion Pump
- Recall number
- Z-1335-04
- Recalling firm
- Nipro Diabetes Systems, Inc.
- Product
- Amigo Insulin Infusion Pump
- Status
- Terminated
- Initiated
- 2004-05-07
- Posted
- 2004-09-14
- Terminated
- 2012-05-03
- 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.
- Lot, serial or model codes
- Model #s 990001, 990002, 990003, 990004, 990005 and 990006. all associated codes, all units distributed have been recalled.
- 510(k) numbers
- ["K013309"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3003352163
- Firm city
- Miramar
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28