Events

Safety Alert for # Trade Name: Microcannulas. . # Registration with ANVISA nº 10250740004.. # Models: 30x0,5mm, 30x0,6mm, 30x0,7mm, 25x0,8mm; 40x0.8mm; 40x0.9mm; 50x0.8mm; 50x0.9mm; 50x1.0mm; 70x0.9mm; 70x1,0mm; 70x1,2mm; 80x1,2mm; 100x2,1mm; 50x0.8mm from Nácul; 50x1.0mm Nácul; 70x1.0mm from Nácul; 50x0.9mm from Nácul; 25x0.8mm Double Hole; 40x0.8mm Double Hole; 40x0.9mm Double Hole; 50x0.8mm Double Hole; 50x0.9mm Double Hole; 50x1,0mm Double Hole; 70x0.9mm Double Hole; 70x1,0mm Double Hole; 70x1,2mm Double Hole; 80x1,2mm Double Hole; 100x2,1mm Double Hole Disposable.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOMEDICAL COMERCIO INDUSTRIA IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS BIOMÉDICOS 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
    1215
  • Date
    2012-12-20
  • 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 must proceed with the collection of units sold.
  • Reason
    Manufacture of the product in a place without sanitary permit and without authorization of operation in this agency.
  • Action
    ANVISA determined the suspension of the manufacture, distribution, distribution, trade and use of the product throughout the national territory, as well as the collection of all units.

Device

# Trade Name: Microcannulas. . # Registration with ANVISA nº 10250740004.. # Models: 30x0,5mm, 30...

Manufacturer

BIOMEDICAL COMERCIO INDUSTRIA IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS BIOMÉDICOS LTDA
  • Source
    ANVSANVISA