Events

Safety Alert for CARTOONBOX - Anvisa Record nº 80228060001 - All sizes - Affected lots - See annex. http://en.wikipedia.org/w/index.php/

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by CARTOON INDUSTRIA E COMERCIO DE CAIXAS DE PAPELAO 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
    1290
  • Date
    2013-08-30
  • 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
    Investigative procedure of the Technovigilance Unit. PA 25351489988 / 2013-07.
  • Reason
    Failure to comply with iso 13853 tests, carried out by ipt / sp, with the potential to cause damages to users. # update: 10/16/2013: publication of resolution re no. 3,377, dated 09/12/2013, published in dou no. 178, section 1 - page 73, of 09/13/2013, determining the suspension of the manufacture, distribution, trade and use of the product throughout the national territory, as well as the collection of existing stock in the market #.
  • Action
    Immediately interrupt the use of the product, segregate any stock and communicate to the supplier for gathering and destruction.

Device

CARTOONBOX - Anvisa Record nº 80228060001 - All sizes - Affected lots - See annex. http://en.wiki...

Manufacturer

CARTOON INDUSTRIA E COMERCIO DE CAIXAS DE PAPELAO LTDA