Events

Recall of Draeger Babytherm Infant Warmers

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Draegerwerk AG & Co KGaA.

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
    17302
  • Event Initiated Date
    2014-09-05
  • 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: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Reason
    The manufacturer is aware of a case in which a side panel on a babytherm 8010 did not fully slide to the bottom in the corner guide and was not completely locked. the side panel did not open during this incident and no patient was affected., furthermore, if the inner 70mm panels were not always used and if a side panel has not been fully locked into position this may allow the baby's movements to open the side panel - it may be possible for a child to fall out.
  • Action
    Manufacturer to issue advice regarding use

Device

Draeger Babytherm Infant Warmers

Manufacturer

Draegerwerk AG & Co KGaA