Events

Safety Alert for Ultrafiltration Removal Regulator (UF) code 6001276024 for hemodialysis machine SYSTEM 1000, TINA, ALTRATOUCH and AURORA .. Lots: 01095126 and 01092479 - Registro ANVISA: 10068390356

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
    849
  • Date
    2006-11-30
  • 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
    Company clarifies that because these regulators seem to be identical to the properly assembled regulators, this incorrect assembly may result in a failure in instrument calibration and early patient therapy. Since this calibration failure occurs prior to patient use of the machine, there is no clinical risk to the patient. Check that the Ultrafiltration Removal Regulators, lots 01095126 and 01092479 are in stock, if available contact your local dealer or Baxter - Quality Assurance Department at: 11 - 5694.8877.
  • Reason
    Ultrafiltration removal regulator, batches: 01095126 and 01092479 were assembled incorrectly.
  • Action
    Urgent Letter of Receipt of Product sent to its customers

Device

Ultrafiltration Removal Regulator (UF) code 6001276024 for hemodialysis machine SYSTEM 1000, TINA...

Manufacturer

BAXTER HOSPITALAR LTDA
  • Source
    ANVSANVISA