Events

Recall of Device Recall MAQUET

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
    70257
  • Event Risk Class
    Class 1
  • Event Number
    Z-1051-2015
  • Event Initiated Date
    2015-01-12
  • Event Date Posted
    2015-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132643
  • 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
    Defects: cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm iso female connector.
  • Action
    Consignees were notified by an Urgent - Field Safety Notice, dated 01/12/2015. The letter identified the affected devices, a description of the problem, and actions to be taken. Customers were asked to check their inventory for any affected product, to cease use and distribution, and immediately quarantine any affected product. Customers are to complete and return the Acknowledgement form and to their local MAQUET representative, who provide a return number. A credit will be issues upon receipt of the affected product. Customer should contact their local MAQUET representative at fieldactions@maquet.com with questions or for support this issue.

Device

Device Recall MAQUET
  • Model / Serial
    Lot numbers: 201413, 201414, 201415, 201417, 201419 and 201422.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to FL, KS, MI and WV.
  • Product Description
    MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. || 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 Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA