Events

Recall of Device Recall Oxylog 3000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical Systems, 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
    56600
  • Event Risk Class
    Class 2
  • Event Number
    Z-0018-2011
  • Event Initiated Date
    2010-08-19
  • Event Date Posted
    2010-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94060
  • 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
    Facility Use Continuous Ventilator - Product Code CBK
  • Reason
    Patients received insufficient ventilation. the oxylog 3000 instructions are inadequate relating to dead space volume.
  • Action
    The firm sent Important Safety Notice Letter, dated August 2010, and Instructions for Use supplement to consignees. The letter explained the issue with the affected product. The letter asks customers to attach the Instructions for Use amendment sheet supplied with the letter to their corresponding Instructions for Use. The firm also states that a they will provide a dedicated pediatric breathing circuit for the Oxylog 3000. Questions regarding the letter should be directed to Michael Kelhart at 1-800-543-5047. Questions regarding the use of the device should be directed to DragerService Technical Support at 1-800-543-5047 or your local Drager Sales Representative.

Device

Device Recall Oxylog 3000
  • Model / Serial
    only units manufactured before 9/08
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
  • Manufacturer
    Draeger Medical Systems, Inc.

Manufacturer

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