Events

Recall of WATER TRAPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    81065
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-15
  • 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
    Occlusion of specific lots of d-fend/d-fend+ water traps could occur immediately after replacement. this water trap occlusion could cause a loss of respiratory airway gas monitoring. when this issue is detected the connected monitoring device will issue an audio alarm and display "low gas sample flow" "replace water trap" or "sampling line blocked" warning messages. unattended or prolonged warnings could lead to an adverse clinical situation if the co2 value would rapidly change in certain clinical conditions.

Device

WATER TRAPS

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)