Events

Alerte De Sécurité sur SWAB STEM PLASTIC WITH STUART, Registration nº 10369460050, lot 20110312 Manufacture 12/03/2011, Validity 12/03/2016 and lot 20110814 Manufacture 14/05/2011, Validity 8/14/2016

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 Labor Import.

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
    1207
  • Date
    2012-11-30
  • 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 the manifestation of the company the use of the product with quality deviation can lead to the result of altered biological culture. In compliance with RDC 23/2012, the company also informs that the available units were identified, collected and destroyed on 09/09/2012. If a customer still identifies a unit in their inventory, please contact the company to arrange for the product to be collected by e-mail sac@laborimport.com.br or telephone (11) 4197-5980. //// UPDATE 10/01/2014 - The company submitted a form finalizing the field action, considering that there was no further contact of customers for the return of the product since February 2013.
  • Cause
    The product presented an unsatisfactory result regarding the appearance and sterility tests, according to the report of analysis nº 981.Cp / 2012, for lot 20110312, manufacture 12/03/2011, validity 03/12/2016 and report of analysis 980.00 / 2012, for lot 20110814 manufacture 14/05/2011, validity 08/14/2016, issued by the instituto adolfo lutz.
  • Action
    The Sanitary Surveillance of the Municipality of São Paulo determined the definitive ban on affected lots, through the publication in the Official Gazette of the City of São Paulo (DOC), Comunicados COVISA no. 029/2012 and Notice COVISA Nº. 34/2012, of 07/28/2012 and 08/08/2012, respectively.

Device

SWAB STEM PLASTIC WITH STUART, Registration nº 10369460050, lot 20110312 Manufacture 12/03/2011, ...

Manufacturer

Labor Import
  • Source
    ANVSANVISA