Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Vascutek Limited.

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
    Recall / Field Safety Notice
  • Event ID
    mdprc 070 07 14 000
  • Event Initiated Date
    2014-07-16
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6145
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    This notice is to inform you about important updates to the above products and their instructions for use (ifu).

Device

Gelweave, Thoraflex Hybrid, BioValsalva Stentless Biplex, Stented BioValsalva Biplex and RVOT ela...
  • Model / Serial
    -All Gelsoft™, Gelsoft Plus™, K-Thin, Gelsoft Plus™ ERS, K-Thin ERS, Gelseal™, Gelseal Plus™, Gelseal™ ERT and Gelweave™ Vascular Prostheses -All Thoraflex™ Hybrid Devices -All BioValsalva™ Stentless Biplex™ Conduits -All Stented BioValsalva™ Biplex™ Conduits -All RVOT elan™ Biplex™ Conduits Lot/Serial Number : All Lots
  • Product Description
    Disposables
  • Manufacturer
    Vascutek Limited

Manufacturer

Vascutek Limited
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Manufacturers representative
    Gulf Medical Co., (012) 6512828
  • Source
    SFDA