Events

Safety Alert for Surgical Surgical Lens, Registration nº 10201230077 - Lots 2149701; 2149801; 2299701; 2149802; 2299702; 2149803; 2149804; 2149805; 2299703; 2149707; 2149712; 2149807; 21498

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
    1429
  • Date
    2014-09-26
  • 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 factory audit performed within the maintenance process of the Seal of Identification of Conformity demonstrated that the company changed the sterilization process for the product, being in disagreement with the information sent to ANVISA.////////// UPDATE: The company completed the field action, according to report sent on the date of 01/29/2015.
  • Reason
    Suspension of authorization for the use of the conformity identification seal by the product certification body (ocp) motivated by the factory audit where it was noted that the surgical gloves were sterilized by a different method from the product registration.
  • Action
    Company shall initiate Field Action for the collection of products manufactured from the date of the last factory audit, held on April 23 and 24, 2014.

Device

Surgical Surgical Lens, Registration nº 10201230077 - Lots 2149701; 2149801; 2299701; 2149802; 22...

Manufacturer

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