Events

Recall of The ConchaTherm Neptune Heated Humidifier

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

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
    70895
  • Event Risk Class
    Class 2
  • Event Number
    Z-1558-2015
  • Event Initiated Date
    2015-04-01
  • Event Date Posted
    2015-04-30
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135428
  • 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
    Customer complaints were received of power to the unit ceasing and the display going blank.
  • Action
    Teleflex sent an Urgent - Medical Device Notification letter dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were informed that Teleflex Medical would exchange all of the potentially impacted units in the field with the Neptune¿ Heated Humidifier with ConchaSmart" Technology. In the meantime, they were instructed to continue to follow hospital and departmental protocol regarding the regular monitoring of the patient and the product during treatment. If the unit display is blank, replace it with another unit and call Teleflex for an immediate replacement. A Recall Acknowledgement Form was attached to be completed, scanned and returned to Teleflex Medical to document receipt of this Notification. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.

Device

The ConchaTherm Neptune Heated Humidifier
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide and Internationally to the countries of: Belgium and Japan
  • Product Description
    Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA