Events

Safety Alert for Catheter Stencil DP PED. Item 3082091 - Code 824204

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratorios 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
    702
  • Date
    2003-04-22
  • 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
    1 - Verify that you received a letter from Laboratorios B. Braun SA (Recall notification). 2 - Identify and isolate the batch mentioned. 3 - For more information, contact Laboratorios B. Braun S / A by telephone (21) 2602.3268, or your local representative. File date 03.03.2004, the company informs the completion of the recall.
  • Reason
    Quality deviation in the product catheter skeleton dp ped, lot 3082091. the deviation refers to the difficulty in adapting the connection equipment to the catheter. problem that was caused by a failure in the product assembly process and is restricted to the aforementioned lot.
  • Action
    B.Braun Laboratories informs that it has decided as a preventive measure to collect lot 3082091 of the product Catheter Stiletto DP PED in the whole national territory.

Device

Catheter Stencil DP PED. Item 3082091 - Code 824204

Manufacturer

Laboratorios B. Braun S.A
  • Source
    ANVSANVISA