Events

Recall of Halyard KimVent Subglottic Suctioning Endotracheal Tubes

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Kimberly-Clark Corp.

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
    17784
  • Event Initiated Date
    2014-12-02
  • 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: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 54 Carbine Road, Mt Wellington, AUCKLAND
  • Reason
    Halyard health's quality assurance processes have identified that the inflation line of certain kimvent* microcuff* subglottic suctioning endotracheal tubes may detach from the endotracheal tube during use (i.E., if pulled, tugged, or excess tube/patient movement occurs). detachment of the inflation line leads to gradual deflation of the endotracheal tube cuff potentially leading to respiratory circuit air leak between the cuff and tracheal wall.
  • Action
    Product to be returned to supplier

Device

Halyard KimVent Subglottic Suctioning Endotracheal Tubes

Manufacturer

Kimberly-Clark Corp