Events

Alerte De Sécurité sur Name of INTRAFIX PRIMELINE AIR IL Technical Name: Family of Gravitational Infusion Equipment for Parental Solutions and Medications ANVISA Registration Number: 80136990540 Hazard Class: II Model Affected: 401450P Serial Numbers Affected: 17A20LB026

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Laboratórios B. Braun S.A..

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
  • ID de l'événement
    2270
  • Date
    2017-04-13
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    Interruption of the use of said lot numbers, segregation thereof and information to Laboratorios B. Braun SA, for collection.
  • Cause
    By means of the publication in official gazette of the state of rio de janeiro of april 12, 2017 (year xliii - no. 068 part i), portaria svs no. 90, dated march 23, 2017, the subsecretariat for health surveillance ( suvisa) determines, as a measure of sanitary interest, the prohibition, suspension of sale and use, and collection of the batch of related product described, within the scope of the state of rio de janeiro. importantly, we have historically had no recorded complaints, or occurrences of adverse events involving the product batch in question. however, b. braun laboratories is initiating a recall with the product involved, throughout the national territory.
  • Action
    Field Action Code AC / 03/2017 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for further destruction.

Device

Name of INTRAFIX PRIMELINE AIR IL Technical Name: Family of Gravitational Infusion Equipment for ...

Manufacturer

Laboratórios B. Braun S.A.