Events

Safety Alert for CERTOFIX DUO V 720 JUG 7F and CERTOFIX DUO V 730 SUB 7F Technical name: FAMILY OF CENTRAL VENOUS CATHETERS ANVISA Registration Number: 80136990671 Hazard Class: IV Affected Model: 4161211 and 4161319 Serial Numbers Affected: 16M15A8551 and 16M21A8551

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
    2212
  • Date
    2017-03-03
  • 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
    Interruption of the use of said lot numbers, segregation thereof and information to Laboratorios B. Braun SA, for collection.
  • Reason
    We have communicated that the possibility of disconnection between the female luer connector and the certofix catheter extension line has been identified. such deviation was identified by the manufacturer during the production process because the female luer connector was not fully inserted in the extension line.
  • Action
    Field Action Code AC / 01/2017 triggered under the responsibility of the company Laboratorios B. Braun SA Company will make payment.

Device

CERTOFIX DUO V 720 JUG 7F and CERTOFIX DUO V 730 SUB 7F Technical name: FAMILY OF CENTRAL VENOUS ...

Manufacturer

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