Events

Safety Alert for GLASS BOTTLE FOR PLASMA HARVESTING AND STORAGE (PLASMACOL)

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
    673
  • Date
    2002-08-21
  • 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
    The product PLASMACOL - glass bottle for plasma collection and storage had the application for registration refused in accordance with Administrative Rule 1376 chapter 3, item 1.1. III - DONOR BLOOD COLLECTION 1. General Instructions 1.1. The collection of blood from the donor should be done aseptically through a venipuncture using a closed system of specially designed plastic bags, disposable, pyrogen-free and sterile
  • Reason
    Rejected pursuant to ordinance no. 1376, chapter 3, item 1.1, portfolio n ° 1376, of november 19, 1993 approves amendments to administrative rule no. 721 / gm, of 08/09/89, approving technical norms for the collection, processing and transfusion of blood, components and derivatives, and other measures.
  • Action
    operated for manufacturing and exposing the sale PLAMACOL - vacuum glass bottle for plasma collection and storage, contrary to current health legislation. Interdicted as a measure of health interest

Device

GLASS BOTTLE FOR PLASMA HARVESTING AND STORAGE (PLASMACOL)

Manufacturer

Laboratorios B. Braun S.A
  • Source
    ANVSANVISA