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

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.

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.