Events

Recall of Device Recall Concha Therm Neptune Heated Humidifier

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Telefelx 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
    54232
  • Event Risk Class
    Class 2
  • Event Number
    Z-1040-2010
  • Event Initiated Date
    2010-01-12
  • Event Date Posted
    2010-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87913
  • 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 - Product Code BTT
  • Reason
    When turned on, the neptune heater may cause an artifact on the patient's heart monitor.
  • Action
    Teleflex consignees were notified via Urgent Medical Device Recall letter via next day delivery on/about 01/12/2010. They were asked to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responders on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be reworked with software upgrade and placed back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. Records will be maintained accordingly.

Device

Device Recall Concha Therm Neptune Heated Humidifier
  • Model / Serial
    Product numbers: 425-00, 425-10 and 525-30, All lot and serial numbers.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland.
  • Product Description
    Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Manufacturer Address
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA