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 Smiths Medical..

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 060 01 11 000
  • Event Initiated Date
    2011-01-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=75
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Reason
    Kinking of the tubing on the level one normothermic iv administration set. the kinking occurs on the small tubing coming out of the heat exchanger. this kinking is sometimes detected by the user when he opens the package, but sometimes, the kinking appears during the use of the level one. this kinking results in an important reduction of the flow, without any alarm. therefore, if the kinking is not seen quickly by the user, it can lead to an important under-infusion.

Device

Sets for Fluid Warmer Level One
  • Model / Serial
    Model No. DI-65HL
  • Product Description
    Sets for Fluid Warmer.
  • Manufacturer
    Smiths Medical.

Manufacturer

Smiths Medical.
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB, Riyadh, (01) 4771374
  • Source
    SFDA