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 Roche Diagnostics Corp.

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 010 03 11 000
  • Event Initiated Date
    2011-03-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=177
  • 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
    Roche conclude that potentially the distance between the needle cut and the end of the soft cannula can be too small, causing or contributing to such an impaired insertion. there is no reliable measure which could be taken by the patient to detect a suspect device before or during use, despite of increasing blood glucose values detected through regular monitoring.

Device

Accu-Chek FlexLink Plus, Infusion administration set
  • Model / Serial
    GWX 001 up to GWX 206 GWY 001 up to GWY 034
  • Product Description
    Infusion administration set, insulin
  • Manufacturer
    Roche Diagnostics Corp

Manufacturer

Roche Diagnostics Corp
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY
  • Source
    SFDA