Events

Recall of Fisher & Paykel RT008 Air Entrainer

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    15355
  • Event Initiated Date
    2013-09-13
  • 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
    Fisher & paykel healthcare (fph) has become aware that the rt008 entrainers with lot number 130726 may potentially be difficult to rotate. our risk evaluation identified no safety risk for this issue. however, it can potentially cause user inconvenience and a replacement may be required.
  • Action
    Product to be exchanged

Device

Fisher & Paykel RT008 Air Entrainer

Manufacturer

Fisher and Paykel Healthcare Ltd