Events

Safety Alert for Interface with patient of the disposable extravasation sensor, model: XDS PID Interface with patient of the disposable extravasation sensor, registration 80172899003, hazard class I, lot 30235.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medrad do Brasil, Distribuição, Importação de Equipamentos e Produtos Médicos e Serviços técnicos Ltda.; Medrad INC..

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
    1796
  • Date
    2015-01-13
  • 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
    There is no risk of using the product once the customers have received the requested product.
  • Reason
    Identified absence of the nationalization label on the product being distributed.
  • Action
    Gathering and destruction. Action code: 2015 / DEV / 017692. The company directs customers to verify the presence of the product in the company's stock. If identified, discontinue use and segregate. The customer must contact the company so that a product recall and replacement authorization is generated.

Device

Interface with patient of the disposable extravasation sensor, model: XDS PID Interface with pati...

Manufacturer

Medrad do Brasil, Distribuição, Importação de Equipamentos e Produtos Médicos e Serviços técnicos...
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    ANVSANVISA