Events

Recall of Device Recall Servo Humidifier 163

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
    74681
  • Event Risk Class
    Class 2
  • Event Number
    Z-2374-2016
  • Event Initiated Date
    2015-12-03
  • Event Date Posted
    2016-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148176
  • 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
    Cracks may occur at the 15mm and 22mm iso female connector.
  • Action
    Inmed, a division of Teleflex sent an Urgent Field Safety Notice letter dated December 3, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, cease use and distribution of stock of the affected product batch and quarantine immediately.. The letter included an acknowledgment form which was to be completed and returned your MAQUET representative. For further information or support concerning this issue, contact your local MAQUET representative at fieldactions@maquet.com. For questions contact your local sales representative or Customer Service.

Device

Device Recall Servo Humidifier 163
  • Model / Serial
    Lots 201450, 201451, 201452, 201504
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of FL, KS and WV.
  • Product Description
    Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 || Product Usage: || A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville NC 27560-5437
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA