Events

Safety Alert for Trade Name: Closed System Urine Collection Fellowships Technical Name: Collectors ANVISA Registration Number: 80136990508 Hazard Class: I Model Affected: UREOFIX 500 CLASSIC, EB. 2.0L, TUBE 120CM (4417930) Serial numbers affected: Item 4417930 / lot: 16F01E8SUA.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A.; B. Braun Melsungen AG.

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
    2118
  • Date
    2016-11-04
  • 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
    Take measures to ensure that the use of the product units belonging to the abovementioned lot is interrupted and segregate the remaining units so that they can be collected by Laboratorios B. Braun SA
  • Reason
    A change in performance of the ureofix 500 classic hourly diurese manifold has been identified. this is due to the possibility of the first compartment of the product emptying its contents before it is completely filled, migrating the urine into the second compartment of this collector. emptying the first compartment makes it difficult to read the patient's diuresis.
  • Action
    Field Action Code AC / 04/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for further destruction.

Device

Trade Name: Closed System Urine Collection Fellowships Technical Name: Collectors ANVISA Registra...

Manufacturer

Laboratórios B. Braun S.A.; B. Braun Melsungen AG