Recall of Device Recall Humidifier Adaptor 040

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
  • Action
    Consignees were notified by letter on 06/06/2014.


  • Model / Serial
    Product Code: 000-40, Lot numbers: AA19, AB12, AC20, AE03, AE18, AE21, AF09, AF16, AG10, AG12 & AH11.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.
  • Product Description
    Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.
  • Manufacturer


  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
  • Source