Events

Field Safety Notices about Biogaze Compressen

According to Inspectie Gezondheidszorg en Jeugd, this field safety notices involved a device in Netherlands that was produced by NOVUM PHARMA BV.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-06-20
  • Event Country
    Netherlands
  • Event Source
    IGJ
  • Event Source URL
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2017/06/20/field-safety-notice-novum-pharma-bv-biogaze-compressen
  • Notes / Alerts
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Extra notes in the data
  • Reason
    In the aforementioned batches , the item "sterile" appears on the packaging. this has been done in error since a notified body is not enabled to classify it as a sterile medical device.

Device

Biogaze Compressen

Manufacturer

NOVUM PHARMA BV