Events

Recall of Concha IV Plus Heated Humidifier

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hudson Respiratory Care 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
    28916
  • Event Risk Class
    Class 2
  • Event Number
    Z-0929-04
  • Event Initiated Date
    2004-04-20
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32792
  • 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
    Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
  • Reason
    Software malfunction. the humidifier did not retain the clinician selected default settings for temperature gradient, after the unit had been placed in the "pause" mode.
  • Action
    Firm will call hospitals to arrange for a visit to update the software.

Device

Concha IV Plus Heated Humidifier
  • Model / Serial
    All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Concha IV Plus Heated Humidifier
  • Manufacturer
    Hudson Respiratory Care Inc

Manufacturer

Hudson Respiratory Care Inc
  • Manufacturer Address
    Hudson Respiratory Care Inc, 27711 Diaz Rd, Temecula CA 92590-3425
  • Source
    USFDA