Events

Recall of Insulin Pump Model R1000

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
    33950
  • Event Risk Class
    Class 2
  • Event Number
    Z-0306-06
  • Event Initiated Date
    2005-10-31
  • Event Date Posted
    2005-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42777
  • 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
    Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
  • Action
    The recalling firm telephoned the users on 10/31/05 to inform them of the problem and that the pump would be replaced if the user choose to return it.

Device

Insulin Pump Model R1000
  • Model / Serial
    Model number R1000
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The pumps were shipped to patients CA, CO, FL, IL, KS, MA, MI, NJ, NY, NC, NV, PA,TN, TX, WI, and WV.
  • Product Description
    Isulin Pump. Models R1000
  • Manufacturer
    Animas Corporation

Manufacturer

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