Events

Recall of Merit/47258/Manifold Kits

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Merit Medical Systems Inc.

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
    20513
  • Event Initiated Date
    2016-08-24
  • 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
    Due to supplier moulding defect in the drip chamber prior to use and during prep, when contrast is drawn out of the contrast bottle air may be drawn into the contrast fluid channel from the vent channel resulting in the contrast having excessive air bubbles which can cause the burette to empty quickly and the blue ball to drop to the bottom of the chamber interfering with the contrast administration.
  • Action
    Product to be returned to supplier

Device

Merit/47258/Manifold Kits

Manufacturer

Merit Medical Systems Inc