Events

Recall of Laerdal Suction Unit (78xxxx)

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
    20703
  • Event Initiated Date
    2016-10-10
  • 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
    This is a follow-up to the initial communication, to provide information on a long-term solution, with regards to the laerdal suction unit (lsu) when used with the lsu nimh battery that has been stored or installed at low temperatures for a prolonged period.
  • Action
    Instructions for use to be updated

Device

Laerdal Suction Unit (78xxxx)
  • Model / Serial
    Model: , Affected: 7800033 LSU WITH RESUABLE CANISTER WITH NIMH BATTERY, 78001033 WITH ABBOT RECEPTAL CANISTER WITH NIMH BATTERY, 78002033 LSU WITH BEMIS CANISTER WITH NIMH BATTERY, 78003033 WITH SERRES SUCTION BAG CANISTER SYSTEM WITH NIMH BATTERY
  • Manufacturer
    Laerdal Medical AS

Manufacturer

Laerdal Medical AS