Events

Safety Alert for LATEX GLOVE FOR NON-STERILE PROCEDURE (WITHOUT POWDER), Registration No. 10201230123

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; Terang Nusa SDN.BHD.

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
    1346
  • Date
    2014-01-21
  • 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
    The Technovigilance Unit will be monitoring compliance with the field action. ////// UPDATE - 08/13/2014 - The company sent a report on the conclusion of the product collection action. 421,700 units were collected. The products collected and those in the company's inventory were sent to the company Momento Engenharia Ambiental for waste treatment, according to certificate nº 34499/2014.
  • Reason
    Suspension of authorization for the use of the identification seal of compliance by the product certification body (ocp) motivated by the failure in the semi-annual maintenance tests, according to reports ela / l-238.899 / 13; ela / l-240.743 / 1/14, issued by the ocp.
  • Action
    Company should trigger Field Action. ///// UPDATE - 08/13/2014 - The company finalized the field action.

Device

LATEX GLOVE FOR NON-STERILE PROCEDURE (WITHOUT POWDER), Registration No. 10201230123

Manufacturer

Embramac- Empresa Brasileira de Materiais Cirúrgicos, Indústria, Comércio, Importação e Exportaçã...