Events

Recall of Laerdal Suction Unit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Laerdal Medical AS.

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
    20417
  • Event Initiated Date
    2016-08-03
  • 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: Laerdal (New Zealand) Ltd, Unit O, Cain Commerical Centre, 20 Cain Road, Penrose
  • Reason
    There has been a problem identified that is related to use of the laerdal suction unit (lsu) when used with the lsu nimh battery that hase been stored or installed at low temperatures for a prolonged period., the problem may occur if the lsu with a nimh battery, or the nimh battery, has been stored at low temperatures so that the core temperature of the nimh battery is low, typically between 0 °c and 9 °c (32 °f to 48 °f). if used with a nimh battery with low core temperature, the lsu may shut off after some seconds when operated at 350 mmhg or 500+ mmhg (46.6 kpa or 66.5+ kpa) settings.
  • Action
    Manufacturer to issue advice regarding use

Device

Laerdal Suction Unit

Manufacturer

Laerdal Medical AS