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 Abbott Vascular Devices Div Abbott Laboratories 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 010 12 13 000
  • Event Initiated Date
    2013-12-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4860
  • 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
    Abbott vascular has initiated a voluntary field action for ht connect peripheral guide wires due to a small number of devices exhibiting partial delamination of the ptfe coating.

Device

HT Connect Peripheral Guide Wires
  • Model / Serial
    Part Number : Description 1012587 : 018 HT CONNECT 145 CM 1012588 : 018 HT CONNECT 195 CM 1012589 : 018 HT CONNECT 300 CM 1012590 : 018 HT CONNECT FLEX 145 CM 1012591 : 018 HT CONNECT FLEX 195 CM 1012592 : 018 HT CONNECT FLEX 300 CM 1012593 : 018 HT CONNECT 250T 145 CM 1012594 : 018 HT CONNECT 250T 195 CM 1012595 : 018 HT CONNECT 250T 300 CM
  • Product Description
    Guide wires
  • Manufacturer
    Abbott Vascular Devices Div Abbott Laboratories Inc

Manufacturer

Abbott Vascular Devices Div Abbott Laboratories Inc
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Manufacturers representative
    Gulf Medical Co., Jeddah, (02) 6512828
  • Source
    SFDA