Events

Recall of Ambu Laryngeal Mask, single-use

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ambu 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
    19585
  • Event Initiated Date
    2015-12-18
  • 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: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • Reason
    Potential sterility breach., a failure has been discovered during routine quality control at the manufacturing site., this failure may cause a small hole, (approximately 0.5mm) in the pouch of the device leading to a potential compromised sterile barrier., after identification of failure, comprehensive investigation has shown a low prevalence of up to 3% for the affected lots., manufacturer has not received any complaints or other market feedback on the matter, dating from when the products were marketed in 2014., .

Device

Ambu Laryngeal Mask, single-use
  • Model / Serial
    Model: AMB408-300-000, Affected: 1794260, 1745425, 1724948, 1794260, 1729556, 1724950, 1732622
  • Manufacturer
    Ambu AS

Manufacturer

Ambu AS
  • Manufacturer Parent Company (2017)
    Ambu A/S
  • Source
    NZMMDSA