Events

Field Safety Notices about Gammex PF

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 Ansell N.P Sdn. Bhd..

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
    243
  • Date
    2015-10-16
  • 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

Gammex PF
  • Model / Serial
    Catalog Number: 351141 to 351149 (9 sizes) Batch Number: 1411591004 1411595604 1412600604 1412602604 1412604004 1412612804 1501409504 1503446404
  • Product Description
    Medical devices for single use
  • Manufacturer
    Ansell N.P Sdn. Bhd.

Manufacturer

Ansell N.P Sdn. Bhd.
  • Manufacturer Parent Company (2017)
    Ansell Ltd.
  • Source
    MHSIDCCCDMIS