Events

Recall of Humidiflow

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

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
    37863
  • Event Risk Class
    Class 2
  • Event Number
    Z-0935-2007
  • Event Initiated Date
    2007-04-26
  • Event Date Posted
    2007-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51985
  • 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
    Respiratory Gas Humidifier - Product Code BTT
  • Reason
    The intake filter of the humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (if the filter were to come in contact with the fan blades this could stop the fan from operating and cause the concentrator to overheat and interrupt the flow of oxygen to the patient).
  • Action
    Customers were notified via a letter dated April 26, 2007. The letter describes the problem and product. Included with the letter, is a correction kit and installation instructions. The letter also urges the consignee to take an action to fill the attached form to confirm that the new intake filter restaint has been installed.

Device

Humidiflow
  • Model / Serial
    Model # HMK-RM Lot # 072849001 Serial #''s: 1009202067, 1027061A, 100920067, 1109061, 102020061B, 102020061 (1009202067 has 28 Humidiflow kits ;1027061A has 29 kits;100920067 has 20 kits;1109061 has 42 kits;102020061B has 20 kits;102020061 has 39 kits0
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    WORLDWIDE DISTRIBUTION: USA including states of GA, MO, FL, UT, CO, TX, MT, MN, PA, OH, AL, SC, VA, KY, IA, MA, TN, IL, NM, UT, NJ, IN, and WI, and countries of CANADA, MEXICO, and JAPAN.
  • Product Description
    HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM
  • Manufacturer
    Porous Media Corporation

Manufacturer

Porous Media Corporation
  • Manufacturer Address
    Porous Media Corporation, 1350 Hammond Rd, Saint Paul MN 55110-5865
  • Source
    USFDA