Events

Recall of Device Recall Amigo

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nipro Diabetes Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29436
  • Event Risk Class
    Class 2
  • Event Number
    Z-1335-04
  • Event Initiated Date
    2004-05-07
  • Event Date Posted
    2004-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33738
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, Infusion, Insulin - Product Code LZG
  • Reason
    A fda inspection of the firm revealed deficiencies in the company's quality system. problems exhibited may include motor failure or unintended operation.
  • Action
    The firm will notify each distributor and user by letter and/or telephone of the recall.

Device

Device Recall Amigo
  • Model / Serial
    Model #s 990001, 990002, 990003, 990004, 990005 and 990006. all associated codes, all units distributed have been recalled.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to New York, New Jersey, Florida,Indiana, Utah, Colorado and Wyoming.
  • Product Description
    Amigo Insulin Infusion Pump
  • Manufacturer
    Nipro Diabetes Systems, Inc.

Manufacturer

Nipro Diabetes Systems, Inc.
  • Manufacturer Address
    Nipro Diabetes Systems, Inc., 3801 Commerce Pkwy, Miramar FL 33027
  • Source
    USFDA