Events

Recall of Gyrus Diego Elite Tubesets

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Gyrus ENT LLC.

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
    18519
  • Event Initiated Date
    2015-05-14
  • 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: Olympus (NZ) Ltd, 15D Paul Matthews Road, Albany, Auckland
  • Reason
    The manufacturer is recalling this product due to a possible breach of the package's sterile barrier, therefore compromising the sterility of the product. the breach may not be easily seen.
  • Action
    Product to be returned to supplier

Device

Gyrus Diego Elite Tubesets
  • Model / Serial
    Model: Item Codes: TS100S, TS101DC, Affected: All lots
  • Manufacturer
    Gyrus ENT LLC

Manufacturer

Gyrus ENT LLC