Events

Recall of Device Recall VentStar Oxylog 3000F

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
    74469
  • Event Risk Class
    Class 1
  • Event Number
    Z-2215-2016
  • Event Initiated Date
    2016-05-31
  • Event Date Posted
    2016-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147675
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    Isolated episodes of leakage at the check valve were found.
  • Action
    Drager sent an Urgent Medical Device Recall letter dated May 31, 2016 and Customer Reply and Order Card to all customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to inspect stock and dispose of affected products. For questions regarding this letter call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Dr¿ger device/accessory contact Dr¿gerService Technical Support at 1-800- 543-5047 (press 4 at the prompt).

Device

Device Recall VentStar Oxylog 3000F
  • Model / Serial
    Catalog Number: 5704964
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including states of: AK, CA, FL, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NY,OH,OK,OR,PA,TN,TX,UT,VA,WA, and WI.
  • Product Description
    Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 || The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
  • 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