Events

Safety Alert for Intrafix Compact Air FS - Registration No. 80136990743 - Model 441723P - lots: 14K21LA724, 14K21LA725, 14K21LA726, 14K22LA726, 14K22LA727, 14K22LA728, 14K22LA728, 14K22LA737, 14K22LA737, 14K27LA737,14K27LA738, 14L08LA752, 14L08LA753, 14L10LA753, 14L10LA756, 14L10LA755.

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
    1492
  • Date
    2014-12-19
  • 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, DC Flexible Chamber 2000 (lS322126E) is imported from another unit of group B.Braun (Vietnam). The manufacturer unit has been informed and the problem is under investigation.
  • Reason
    The company holding the registration informs that it has been identified the possibility of leakage in the base of the dc 2000 flexible chamber amber in isolated units of the product.
  • Action
    The company that holds the registration in Brazil requests the interruption of the use, distribution and segregation of said lots still in the customer's stock, information to Laboratorios B. Braun SA of the quantities of existing units of each lot. Any doubt, contact the company: atendimento.Reclamacao@bbraun.com

Device

Intrafix Compact Air FS - Registration No. 80136990743 - Model 441723P - lots: 14K21LA724, 14K21L...

Manufacturer

Laboratórios B. Braun S.A.