Events

Recall of OXYLOG 3000 SYSTEM - DISPOSABLE VENTILATION HOSE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL CANADA 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
    27635
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-03
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    During the course of routine internal testing the firm detected isolated episodes of leakage at the check valve (one way valve of the inspiration branch) of the disposable pediatric ventilation hose of oxylog 3000 system and oxylog plus model 5704964. affected circuits with this fault were potentially distributed to customers. all other ventilation circuits for the oxylog family of devices are not affected. leakage at the check valve can result in patient's exhaled gas entering into the breathing circuit which could lead to the rebreathing of the same exhaled gas with reduced oxygen concentration/elevated co2 for the patient. this leakage is not detected during the ventilator operational readiness check.

Device

OXYLOG 3000 SYSTEM - DISPOSABLE VENTILATION HOSE
  • Model / Serial
    Model Catalog: 5704964 (Lot serial: MFG DATES
  • Product Description
    OXYLOG 3000 SYSTEM - DISPOSABLE VENTILATION HOSE
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.