Events

Recall of Device Recall ezManager Max Diabetes Management System version 2.0.9

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Animas Corporation.

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
    53748
  • Event Risk Class
    Class 2
  • Event Number
    Z-0481-2010
  • Event Initiated Date
    2009-11-02
  • Event Date Posted
    2009-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86454
  • 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
    diabetes management system - Product Code MRZ
  • Reason
    Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
  • Action
    Animas issued an Urgent Medical Device Correction letter dated 11/2/09 to the pump user and another letter to the health care professional that prescribed the pump. The letters explain the issue. The patient letter is accompanied with a CD that contains the upgraded software and instructions to follow.

Device

Device Recall ezManager Max Diabetes Management System version 2.0.9
  • Model / Serial
    version 2.0.9
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution, and Canada, Cayman Islands, and Denmark.
  • Product Description
    Animas ezManager Max Diabetes Management System version 2.0.9
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • Manufacturer Address
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380-3428
  • Source
    USFDA