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 Guangzhou Weini Technology & Development Co., Ltd. (GWT).

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 073 01 13 000
  • Event Initiated Date
    2013-01-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2908
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    N95 particulate respirators were sold as niosh (national institute of occupational safety and health) certified masks in canada. these masks are used to protect the health care professionals from the airborne particulates. the manufacturer, guangzhou weini technology & development co. ltd, (gwt) lost the niosh certification for all of their n95 particulate respirators on december 16, 2009. communication with us centres for disease control indicated that the n95 particulate respirators manufactured by gwt before december 16, 2009 are also no longer certified.

Device

Respirator Mask, All N95 Particulate Respirator

Manufacturer

Guangzhou Weini Technology & Development Co., Ltd. (GWT)