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Terminated

Amigo Insulin Infusion Pump

FDA Recall Z-1335-04 · Posted 2004-09-14

Recalling FirmNipro Diabetes Systems, Inc.
Recall StatusTerminated
Product CodeLZG
Date Initiated2004-05-07
Date Terminated2012-05-03
Product Quantity8 Pumps

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.

Firm Action

The firm will notify each distributor and user by letter and/or telephone of the recall.

Root Cause

Other

Distribution Pattern

Distributed to New York, New Jersey, Florida,Indiana, Utah, Colorado and Wyoming.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013309GLUCOPRO EVO INFUSION PUMPNipro Diabetes Systems, Inc. · 2002-06-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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