Events

Safety Alert for LATEX SLEEVE FOR NON-STERILE PROCEDURE (SIZED) PP SIZE - Registration 10201230064 - All lots.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by EMBRAMAC- EMPRESA BRASILEIRA DE MATERIAIS CIRÚRGICOS, INDÚSTRIA, COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃO LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1072
  • Date
    2011-08-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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 (SBAC). #### UPDATE - 02/24/2012 - The company presents Certificate of destruction of the products collected by the company Momento Engenharia Ambiental - n.º 06920/2011. #### The Certifying Body - Instituto Falcão Bauer da Qualidade - IFBQ, sends a communiqué Ref .: 1484/2012, where it withdraws the suspension subject to this alert, and the product may be marketed normally as of 06/05/2012. ####
  • Reason
    Failure in the annual maintenance tests on the dimensional attribute, as shown in the mechanical test reports ela / l-208.037 / 11 and ela / l-209.820 / 11.
  • Action
    Segregation for destruction of all lots related to the affected model. Contact the record holder.

Device

LATEX SLEEVE FOR NON-STERILE PROCEDURE (SIZED) PP SIZE - Registration 10201230064 - All lots.

Manufacturer

EMBRAMAC- EMPRESA BRASILEIRA DE MATERIAIS CIRÚRGICOS, INDÚSTRIA, COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃ...