Events

Recall of Intersurgical/14085/Laryngeal airway

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Intersurgical 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
    21272
  • Event Initiated Date
    2017-03-30
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Reason
    A manufacturing fault in the tube of the solus flexible laryngeal mask airways can result in partial or total occlusion of the airway tube when the cuff is inflated, which may result in partial or total restriction of air delivery to and/or from the patient.
  • Action
    Product to be returned to supplier

Device

Intersurgical/14085/Laryngeal airway
  • Model / Serial
    Model: , Affected: size 2(small paediatric), size 2.5(large paediatric), size 3(small adult), size 4(medium adult), size 5(large adult) Lots from 31400504 till 31611024
  • Manufacturer
    Intersurgical Ltd

Manufacturer

Intersurgical Ltd