Z-1335-04

Amigo Insulin Infusion Pump

Name: Z-1335-04 Amigo Insulin Infusion Pump
Creator: Nipro Diabetes Systems, Inc.
Published: 2004-05-07
License: https://open.fda.gov/license/

Nipro Diabetes Systems, Inc. / initiated 2004-05-07 / Terminated

FDA source

Nipro Diabetes Systems, Inc. began a recall of Amigo Insulin Infusion Pump on 2004-05-07. The reason FDA records is "A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1335-04
Status: Terminated
Initiated: 2004-05-07
Posted: 2004-09-14
Terminated: 2012-05-03
Recalling firm: Nipro Diabetes Systems, Inc.
Product: Amigo Insulin Infusion Pump
Product code: LZG Pump, Infusion, Insulin
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.
FDA root cause: Other
Action: The firm will notify each distributor and user by letter and/or telephone of the recall.
Quantity in commerce: 8 Pumps
Distribution: Distributed to New York, New Jersey, Florida,Indiana, Utah, Colorado and Wyoming.
Product codes and lots: Model #s 990001, 990002, 990003, 990004, 990005 and 990006. all associated codes, all units distributed have been recalled.

Product code LZG

K013309Class IIGlucopro Evo Infusion PumpNipro Diabetes Systems, Inc. / cleared 2002-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)