Events

Safety Alert for ALL PRODUCTS OF THE COMPANY SANTE TEXTIL LTDA.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by SANTE TEXTIL 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
    1203
  • Date
    2012-11-21
  • 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
    Anvisa takes this measure considering that, in Investigative Inspection on 09/12, the company was not located at the declared address. In addition, the Sanitary Vigilance of Joinvile reported that the company had requested the shutdown of its manufacturing activities in 05/2012. Invoices were evidenced after this date. In Investigative Inspection was spotted production in place without Operation Permit. Anvisa / Utvig follows this case.
  • Reason
    Suspension determination of manufacturing, distribution, trade and use. seizure and destruction of existing stock in the market, according to resolution - re n °. 4,843, dated november 12, 2012. dou n ° 219 of 11/13/2012 attached. http://portal.Anvisa.Gov.Br/wps/wcm/connect/41c92d804d87ef40a4e5e5c116238c3b/re4.843.Pdf?mod=ajperes.
  • Action
    Check the product for stock and segregate. Do not use the product. Contact your local Sanitary Surveillance to monitor product destruction. Contact supplier to negotiate refund.

Device

ALL PRODUCTS OF THE COMPANY SANTE TEXTIL LTDA.

Manufacturer

SANTE TEXTIL LTDA
  • Source
    ANVSANVISA