Events

Recall of Catheter Mount

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fisher & Paykel Healthcare Pty 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
    RC-2017-RN-01310-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01310-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Fisher & paykel healthcare (fph) has been advised of an increased rate of split tubing cuffs in specific catheter mounts. a split tubing cuff on the catheter mount may potentially cause a leak.To date, fph has not received any reports of adverse events however there is the potential that a leak could lead to patient hypoxaemia if undetected.
  • Action
    Fisher & Paykel Healthcare advises customers to identify any affected lot numbers of the RT021 Catheter Mount from their inventory. Affected products should be destroyed and disposed of.

Device

Catheter Mount
  • Model / Serial
    Catheter MountModel Number: RT021 Lot Numbers: From 2100089358 to 2100098462; and From 2100190360 to 2100241254ARTG Number: 273356
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd