Events

Field Safety Notices about Ambu® AuraGain™

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Ambu A/S.

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
  • Event ID
    359
  • Date
    2016-01-11
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

Ambu® AuraGain™
  • Model / Serial
    Catalog Number: 408 300 000 408 400 000 408 500 000 Model Number: Size #3 Size #4 Size #5 Batch Number: 408300000 Size #3:All lots through lot number 1790072 (including this number and lower), except lot number 1756844, 1758852, 1768981, 1771564, 1774137, 1785130, 1787754 408400000 Size #4: All lots through lot number 1810862 (including this number and lower), except lot number 1804456 408500000 Size #5: All lots through lot number 1774140 (including this number and lower), except lot number 1732626 and 1745421
  • Product Description
    Anesthetic and respiratory medical devices
  • Manufacturer
    Ambu A/S

Manufacturer

Ambu A/S
  • Manufacturer Parent Company (2017)
    Ambu A/S
  • Source
    MHSIDCCCDMIS