Events

Alerte De Sécurité sur EQUIPMENT BURETA LA VITA, Registration no. 80288099006, lot: KLB5-120710A, Fab. 10/07/2012, Val. 09/07/2017

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 TKL IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS MÉDICOS E HOSPITALARES LTDA..

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
    1358
  • Date
    2014-02-17
  • 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
    UPDATE - 09/02/2014 - The company completed the field action, the products collected were incinerated by the company SERQUIP - Waste Treatment Company, according to an award report dated 08/20/2014.
  • Cause
    According to the single sample tax report no. 3889.00 / 2013 issued by the adolfo lutz institute of the são paulo health secretariat, the equipment bureta la vita, lot klb5-120710a, was considered unsatisfactory in the test of appearance (foreign body presence).
  • Action
    Resolution No. 489 of 14 February 2014 determined the suspension of distribution, trade and use as well as the collection of the product BURETA LA VITA, lot KLB5- 120710A. ///// UPDATE - 02/09/2014 - The company finished the field action, the products collected were incinerated by the company SERQUIP - Waste Treatment Company, according to an award dated 08/20/2014.

Device

EQUIPMENT BURETA LA VITA, Registration no. 80288099006, lot: KLB5-120710A, Fab. 10/07/2012, Val. ...

Manufacturer

TKL IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS MÉDICOS E HOSPITALARES LTDA.