Events

Alerte De Sécurité sur LATEX SURGICAL GLOVE DESCARPACK (Registro Anvisa: 10330660023).

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
    1038
  • Date
    2010-12-23
  • 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 under the Brazilian System of Conformity Assessment (SBAC). #### 06/30/2011 - The company Descarpack proceeded with the collection and destruction of the remaining products, object of this Sanitary Alert, proven by the Certificate of Co-processing # 02348/2011, issued by the company Environmental Engineering Momento, accompanied by the Municipal Visa of Ilhota / SC. The Authorization for Use of the Seal of Compliance has been reacquired as correspondence of the Falcão Bauer Institute of June 20, 2011. ####
  • Cause
    Suspension of the authorization to use the seal of conformity identification motivated by the disapproval in the semi-annual maintenance test carried out by the falcão bauer institute of quality.
  • Action
    (1) Discontinuation of use and segregation of the product in stock. (2) forward to Anvisa (tecnovigilancia@anvisa.gov.br) the following information: batch / quantitative no. / Date of acquisition. (3) make contact with the record holder for possible recall.

Device

LATEX SURGICAL GLOVE DESCARPACK (Registro Anvisa: 10330660023).

Manufacturer

Descarpack Descartáveis do Brasil Ltda.