Events

Safety Alert for STERILE SURGICAL KIT TECNYL OVER GENERAL USE, Registration nº 10366900027, lots: T00380, T00271, T01471, T01297

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VENKURI INDÚSTRIA DE PRODUTOS MÉDICOS 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
    1280
  • Date
    2013-08-01
  • 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
    According to the manifestation of the company there are risks to the user because it is a sterile product with bacterial, hypoallergenic barrier.
  • Reason
    The company holding the registration identified that the product was marketed with the registration number due. according to the manufacturer the product is sterile and has been produced to the correct specifications, but there is an updated record for this product today (registration no. 10366900045).
  • Action
    The company that owns the registration in Brazil is collecting the product.

Device

STERILE SURGICAL KIT TECNYL OVER GENERAL USE, Registration nº 10366900027, lots: T00380, T00271, ...

Manufacturer

VENKURI INDÚSTRIA DE PRODUTOS MÉDICOS LTDA