Events

Avis De Sécurité sur ACDA-A (Anticoagulant Citrate Dextrose Solution)

Selon Turkey Drugs and Medical Devices Agency (Titck), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Turkey qui a été fabriqué par Biomet 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
    Field Safety Notice
  • ID de l'événement
    2016/804 & HHE CL 15-001
  • Date
    2016-08-03
  • Pays de l'événement
    Turkey
  • Source de l'événement
    TDMDAT
  • URL de la source de l'événement
    https://web.archive.org/web/20170817101933/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-804%20SGB.pdf
  • Notes / Alertes
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notes supplémentaires dans les données

Device

ACDA-A (Anticoagulant Citrate Dextrose Solution)
  • Modèle / numéro de série
  • Description du dispositif
    Class IIB
  • Manufacturer
    Biomet Inc.

Manufacturer

Biomet Inc.
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    TDMDAT