Events

Recall of Device Recall USFilter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by U.S. Filter/Ionpure, 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
    31255
  • Event Risk Class
    Class 3
  • Event Number
    Z-0798-05
  • Event Initiated Date
    2005-02-28
  • Event Date Posted
    2005-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37509
  • 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
    Subsystem, Water Purification - Product Code FIP
  • Reason
    Incorrect type of stainless steel firm used 303 vs 316.
  • Action
    US Filter notified consignees by letter between 3/17 and 3/28/05 advising users of the recall.US Service will field correct and replace units.

Device

Device Recall USFilter
  • Model / Serial
    Models: MRORXO1, MRORXO2, MRORXO3,MRORXO4, MRORXO5, MRORXO6, MRORXO8,MRORXO9, MRORX12. CMRORX01, CMRORX02, CMRORX03, CMRORX04, CMRORX05, CMRORX08  Serial Numbers: 53130 through 60754 (not consecutive)
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada, Mexico
  • Product Description
    MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages
  • Manufacturer
    U.S. Filter/Ionpure, Inc.

Manufacturer

U.S. Filter/Ionpure, Inc.
  • Manufacturer Address
    U.S. Filter/Ionpure, Inc., 10 Technology Dr, Lowell MA 01851-2728
  • Source
    USFDA