Events

Safety Alert for Dialisador CA 210, Lot: A01C04

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar Ltda..

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
    756
  • Date
    2003-11-11
  • 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
    Baxter Hospitalar Ltda reports that: "Previous reports of a similar nature have been associated with the use of dialysers with unmodified cellulose acetate fiber. It is not known to what extent the time and / or storage conditions of the dialysers influence this type of incident. In Brazil we have not received any reports of Red-Eye Syndrome using these dialysers. "///// If your EAS received the batch in question, immediately suspend the use and contact the Manufacturer or your local representative. The Tecnovigilância / ANVISA Unit will be monitoring all actions carried out by the company.
  • Reason
    Reports received from a dialysis clinic in mexico, where 10 patients reported adverse events including conjunctivitis, iritis, malaise, myalgia, and arthralgia combined. these events are related to the syndrome known as "red eye syndrome".
  • Action
    BRAZIL - 11.11.2003 - Baxter Hospitalar Ltda is initiating the voluntary withdrawal of the A01C04 lot from the dialyzer CA 210 by means of a letter dated 11.11.2003.

Device

Dialisador CA 210, Lot: A01C04

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA