Events

Safety Alert for Name of INTRAFIX PRIMELINE AIR IL Technical Name: Family of Gravitational Infusion Equipment for Parental Solutions and Medications ANVISA Registration Number: 80136990540 Hazard Class: II Model Affected: 401450P Serial Numbers Affected: 17A20LB026

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..

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
    2270
  • Date
    2017-04-13
  • 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
    Interruption of the use of said lot numbers, segregation thereof and information to Laboratorios B. Braun SA, for collection.
  • Reason
    By means of the publication in official gazette of the state of rio de janeiro of april 12, 2017 (year xliii - no. 068 part i), portaria svs no. 90, dated march 23, 2017, the subsecretariat for health surveillance ( suvisa) determines, as a measure of sanitary interest, the prohibition, suspension of sale and use, and collection of the batch of related product described, within the scope of the state of rio de janeiro. importantly, we have historically had no recorded complaints, or occurrences of adverse events involving the product batch in question. however, b. braun laboratories is initiating a recall with the product involved, throughout the national territory.
  • Action
    Field Action Code AC / 03/2017 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for further destruction.

Device

Name of INTRAFIX PRIMELINE AIR IL Technical Name: Family of Gravitational Infusion Equipment for ...

Manufacturer

Laboratórios B. Braun S.A.