Events

Safety Alert for DIACAP ULTRA - DIÁLISE FLUID FILTER - Registration 8013990617 - Lots / Series affected - See annex. http://en.wikipedia.org/w/index.php/

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
    1241
  • Date
    2013-04-11
  • 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 manufacturer makes clear that only the Diacap Ultra product more than 10 months after the date of manufacture are affected by this nonconformity. There are no records in the NOTIVISA system to date. UPDATE 10/10/2013 - The company informed ANVISA that the field action was completed, and the products collected were sent to destruction.
  • Reason
    Over time, the residual moisture of the membrane of the diacap ultra products may decrease, causing a reduction in membrane permeability (ultrafiltration coefficient).
  • Action
    The manufacturer recommends discontinuing the use of said lots, segregating them, informing B. Braun SA Laboratories of the quantities of existing units of each batch number. See attached Letter to the Client. http://en.wikipedia.org/w/eng/index.php

Device

DIACAP ULTRA - DIÁLISE FLUID FILTER - Registration 8013990617 - Lots / Series affected - See anne...

Manufacturer

Laboratórios B. Braun S.A.