Events

Recall of APL Valve used on some Fabius GS, Fabius Tiro and Narkomed 6000 series Anesthesia Machines

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical, 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
    30284
  • Event Risk Class
    Class 2
  • Event Number
    Z-0192-05
  • Event Initiated Date
    2004-09-15
  • Event Date Posted
    2004-11-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35610
  • 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
    Gas-Machine, Anesthesia - Product Code BSZ
  • Reason
    Rotating knob of the rotary style apl valve can become separated from the assembly.
  • Action
    The recalling firm issued a letter to their accounts informing them of the problem. The letter also informed the accounts that they would be contacted when the replacement knob was available to schedule the correction.

Device

APL Valve used on some Fabius GS, Fabius Tiro and Narkomed 6000 series Anesthesia Machines
  • Model / Serial
    APL Valve part number MK00625
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical supply companies, medical facilities nationwide. The product was also shipped to a government accounts in AR, FL, ID, LA, MA, MD, ME, NC, NY, OH, TX, VA, and VT. The product was also shipped to Canada, Germany, Korea, China, Australia, Singapore, Switzerland, and England
  • Product Description
    APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines.
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA