Events

Recall of Infant Nasal CPAP Prongs and Bubble CPAP Starter Kits

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-2014-RN-00437-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00437-1
  • 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
    Fph is issuing this recall notice because it has received customer reports relating to certain lot numbers of certain models of nasal cpap prongs detaching from the fph flexitrunk nasal tubing, especially in the presence of mucous and/or moisture. in the event of the affected prongs detaching from the nasal tubing, therapy is likely to be interrupted. this may lead to a patient becoming hypoxic.
  • Action
    FPH is requesting their customers to identify any units form the affected lot and destroy them. An FPH Representative can assist in sourcing a replacement product.

Device

Infant Nasal CPAP Prongs and Bubble CPAP Starter Kits

Manufacturer

Fisher & Paykel Healthcare Pty Ltd