Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Abbott Vascular Devices Div Abbott Laboratories Inc.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 010 12 13 000
  • Date de mise en oeuvre de l'événement
    2013-12-02
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4860
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    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
  • Modèle / numéro de série
    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
  • Description du dispositif
    Guide wires
  • Manufacturer
    Abbott Vascular Devices Div Abbott Laboratories Inc

Manufacturer

Abbott Vascular Devices Div Abbott Laboratories Inc
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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.
  • Représentant du fabricant
    Gulf Medical Co., Jeddah, (02) 6512828
  • Source
    SFDA