Events

Recall of Device Recall MAQUET Servo Humidifier 163

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex, 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
    Recall
  • Event ID
    70127
  • Event Risk Class
    Class 1
  • Event Number
    Z-1008-2015
  • Event Initiated Date
    2014-12-04
  • Event Date Posted
    2015-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132281
  • 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
    Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. if leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.
  • Action
    An Urgent - Field Safety Notice, dated December 4, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were requested to immediately check inventory, discontinue use and distribution, quarantine. Customers were to return the Acknowledgement form and request a return authorization number from their local Maquet representative for affected devices. A credit will be issued upon receipt of the returned affected product. For questions or for support concerning this issue, a local Maquet representative should be contacted at fieldactions@maquet.com.

Device

Device Recall MAQUET Servo Humidifier 163
  • Model / Serial
    Batch Numbers: 201321, 201323, and 201324.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of FL, MI, WV, and KS.
  • Product Description
    MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. || A heat and moisture condenser (artificial 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 humidify gases breathed in by a patient.
  • Manufacturer
    Teleflex, Inc.

Manufacturer

Teleflex, Inc.
  • Manufacturer Address
    Teleflex, Inc., 550 E Swedesford Rd Ste 400, Wayne PA 19087-1601
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA