Events

Recall of Drager VentStar Disposable Breathing circuit 180cm

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Draegerwerk AG & Co KGaA.

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
    16737
  • Event Initiated Date
    2014-05-26
  • 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: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • Reason
    The manufacturer advises there is potential for adhesive residue the size of a finger nail to be found loose in the hose or the packaging around the hose. the risk to the patient if the hose is used with the residue in place, it may enter the patient's lungs.
  • Action
    Product to be exchanged

Device

Drager VentStar Disposable Breathing circuit 180cm
  • Model / Serial
    Model: Part Numbers: 2M86841 & 2M86791, Affected: Batch numbers: 330384.001- 331661.002 & 330384.001 - 331661.002
  • Manufacturer
    Draegerwerk AG & Co KGaA

Manufacturer

Draegerwerk AG & Co KGaA