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 C R Bard Inc.

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 039 08 17 000
  • Event Initiated Date
    2017-08-15
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11405
  • 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
    Bard is issuing a field safety notice to advise users of an update to the instructions for use for the arctic sun® 5000 temperature management system, per the enclosed labelling addendum. this labelling addendum should be used together with the current operator’s manual and service manual for your device and will be included in the labelling of all future units distributed by bard. the labelling addendum advises that periodic servicing and maintenance of the arctic sun® 5000 temperature management system is recommended to reduce the risk of failure of certain components.

Device

ARCTIC SUN® 5000 Temperature Management System
  • Model / Serial
    Product Codes: 5000-01-01, 5000-01-02, 5000-01-07, 5000-01-08
  • Product Description
    Warming/Cooling Units, Patient
  • Manufacturer
    C R Bard Inc

Manufacturer

C R Bard Inc