Safety Alert for Surgical Table for Small, Medium and High Surgery, model BF686-Registro Anvisa: 8000960006

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BARRFAB Indústria e Comércio 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
    1228
  • Date
    2012-04-27
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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 that after the cleaning process, disinfection of metal surfaces using alcohol-based disinfectant should be carried out according to the instructions for use of the equipment - Operating Table for small, medium and high surgery, delivery and obstetrics model 686 (Barrfab, 2006). When using other disinfectants, note that maximum concentration values ​​should not be exceeded. If there is no means to ensure the indicated concentration, active chlorine-releasing compounds (most commonly used compounds, sodium hypochlorite, calcium and lithium) should not be used for disinfection, risk of corrosion to metals. If you have any questions regarding the information contained in this release, please contact the manufacturer at (54) 2628.8808, 2628.8800, 2628.8803 or administracao@barrfab.com.br. The Technovigilance Unit will monitor the progress of the actions.
  • Reason
    Possibility of oxidation / corrosion in some parts of the table.
  • Action
    Customer survey of oxidation / corrosion occurrence or not