Events

Alerte De Sécurité sur NC Trek RX Coronary Dilatation Catheter

Selon National Drugs Administration from El Salvador (DNM), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à El Salvador qui a été fabriqué par ABBOTT VASCULAR.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Classe de risque de l'événement
    Class I
  • Date
    2017-03-22
  • Pays de l'événement
    El Salvador
  • Source de l'événement
    DNM
  • URL de la source de l'événement
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notes / Alertes
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 data from the U.S. and El Salvador.
  • Notes supplémentaires dans les données
  • Cause
    The cause of the alert is due to difficulties in removing the protective cover of the balloon from the catheter, which can lead to problems with inflation and deflation of the balloon. affected lots: 60921g1, 60912g1, 60819g1, 61012g1, 60907g1 the inspection was carried out confirming that 12 units were imported from the affected lots of which only one was commercialized and notified to the health center, the remaining 11 were returned to the manufacturer abbott vascular fedex.
  • Action
    Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment. - Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices

Device

NC Trek RX Coronary Dilatation Catheter

Manufacturer

ABBOTT VASCULAR
  • 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.
  • Source
    NDAESDNM