Recall of Device Recall ThermoFlo 1 HME

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arc Medical 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
  • Event ID
  • Event Risk Class
    Class 3
  • 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
    Condenser, heat and moisture (artificial nose) - Product Code BYD
  • Reason
    Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
  • Action
    Consignees were contacted by telephone on 02/19/2015.


  • Model / Serial
    Product code: 6160, Batch number: 110208-50
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Distributed in CA and NC.
  • Product Description
    ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. || Used as a humidifier in a breathing circuit.
  • Manufacturer


  • Manufacturer Address
    Arc Medical Inc, 4296 Cowan Rd, Tucker GA 30084-4800
  • Manufacturer Parent Company (2017)
  • Source