Events

Alerte De Sécurité sur GLOVE FOR EXAMINATION AND PROCEDURES DESCARPAK SIZE PP - Registration 10330660014 - ALL LOTS.

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 Descarpack Descartáveis do Brasil 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
    1066
  • Date
    2011-07-06
  • 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
    According to DRC 05 of February 15, 2008, surgical gloves and gloves of non-surgical procedures of natural rubber, synthetic rubber or mixture of natural and synthetic rubbers, under sanitary surveillance regime, must meet the conformity certification requirements in the of the Brazilian Conformity Assessment System (SBAC). ### UPDATE - Back to 06/12/2011 - The Certification Body - IFBQ announces the withdrawal of the suspension of the Authorization for Use of the Conformity Identification Seal, through the dossier 776231 / 11-3, considering that the measures adopted by the company were satisfactory for the correction of the problems that led to the cancellation, being the product released for import, commercialization and use.
  • Cause
    Failure to perform annual maintenance tests, as demonstrated by the mechanical test reports ela / l-207.917 / 11 (test) and ela / l-209.412 / 11 (counter-test).
  • Action
    All products relating to this model must be segregated for destruction.

Device

GLOVE FOR EXAMINATION AND PROCEDURES DESCARPAK SIZE PP - Registration 10330660014 - ALL LOTS.

Manufacturer

Descarpack Descartáveis do Brasil Ltda.