Events

Recall of Fisher & Paykel Bubble CPAP Starter Kits

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Fisher & Paykel Healthcare SA de CV.

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
    16543
  • Event Initiated Date
    2014-04-16
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
  • Reason
    Manufacturer has received customer reports relating to certain lot numbers of certain models of the nasal cpap prongs detaching from the fph flexitrunk nasal tubing., fph introducred a new version of nasal cpap prongs in 2013 and the lot numbers and models incorporate this new version. since the release of this new version fph has received reports of the affected prongs detaching from the nasal tubing during use especially in the presence of mucous and/ or moisture.
  • Action
    Product to be destroyed

Device

Fisher & Paykel Bubble CPAP Starter Kits

Manufacturer

Fisher & Paykel Healthcare SA de CV