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 Terumo BCT 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 057 12 18 000
  • Event Initiated Date
    2018-12-16
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13622
  • 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 letter provides information about the new iv pole collar accessory for the spectra optia system. new spectra optia systems will be shipped with an iv pole collar (see figure 1 below in the attached fsn). this feature has been added to avoid a pinch point between the iv pole and the machine while lowering the iv pole. if the operator does not hold onto the iv pole while pressing the iv pole release button, the iv pole may drop in a free fall. if the operator’s hand or any other body part is in the path of the free-falling iv pole, the operator could be injured. because this is an added safety feature, do not remove the collars after they are installed on the iv pole.

Device

Spectra Optia® Apheresis System
  • Model / Serial
    Spectra Optia® Apheresis System
  • Product Description
    Apheresis Units, Blood Donor
  • Manufacturer
    Terumo BCT Inc

Manufacturer

Terumo BCT Inc
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA