Events

Field Safety Notices about Tubing Sets for Hemodialysis / NovaLine®

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 Vital Healthcare 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
    1591
  • Date
    2018-06-22
  • 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

Tubing Sets for Hemodialysis / NovaLine®
  • Model / Serial
    Catalog Number: Model Code Numbers: BL 200 HDF : 955444 BL 207 : 955448 Model Number: BL 200 HDF/ BL 207 Batch Number: All lots manufactured in year 2017 "2017XXXXXXXX" before cut off lots
  • Product Description
    Medical devices for single use
  • Manufacturer
    Vital Healthcare Sdn. Bhd.

Manufacturer

Vital Healthcare Sdn. Bhd.