Events

Safety Alert for SLEEVE FOR NON-SURGICAL PROCEDURE WITH POWDER, Registration No. 10201230096. Lots 2380600, 2380620, 2380621, 2380622, 2380640, 2380641, 2380642, 2380643, 2380644, 2380645, 2380646, 2380647, 2380648, 2380660, and 2380661

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
    1550
  • Date
    2015-03-26
  • 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 company advises customers to segregate the material so that it is collected
  • Reason
    Suspension of authorization for use of the conformity identification seal product certification body (ocp), once the product was disapproved in the annual maintenance tests, which presented non-compliance with iso standard 11.193-1 / 09.
  • Action
    Company is carrying out Field Action for the collection of manufactured products.

Device

SLEEVE FOR NON-SURGICAL PROCEDURE WITH POWDER, Registration No. 10201230096. Lots 2380600, 238062...

Manufacturer

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