Events

Recall of FLEXIBLE NEONATAL SIZE TUBING

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FISHER AND PAYKEL HEALTHCARE LTD..

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
    153071
  • Event Risk Class
    II
  • Event Initiated Date
    2004-09-27
  • 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
    In some instances use of the tubing system in combination with the babylog 8000 respirator leads to an airway pressure alarm when special respiratory parameters are adjusted.

Device

FLEXIBLE NEONATAL SIZE TUBING

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.