Events

Safety Alert for PORTABLE SYSTEM OF REVERSE OSMOSIS. Anvisa Record: 80145240358. Product Codes: 5M5509, 5M5509R, 5M1313, 5M1313R, 5M1293 and FM4644.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Healthcare Corporation; 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
    948
  • Date
    2008-11-03
  • 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
    FILMTEC, a supplier of the FIL FILMTEC filter membranes for BAXTER, made changes to the instructions for use of the membranes. The new information contained in the instructions for use of these membranes is: (1) Saturated water obtained after the first hour of use should be discarded in the drain; and (2) Protective gloves and sleeves to avoid prolonged contact with skin and clothing. Users of the product are encouraged to read and perform these new operating instructions. To access the Letter to Clients disclosed by the company, access: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/948_carta.pdf
  • Reason
    Change of instructions for use of reverse osmosis membranes used in baxter's portable reverse osmosis system.
  • Action
    FILMTEC, a supplier of the FIL FILMTEC filter membranes for BAXTER, made changes to the instructions for use of the membranes. The new information contained in the instructions for use of these membranes is: (1) Saturated water obtained after the first hour of use should be discarded in the drain; and (2) Protective gloves and sleeves to avoid prolonged contact with skin and clothing. Users of the product are encouraged to read and perform these new operating instructions.

Device

PORTABLE SYSTEM OF REVERSE OSMOSIS. Anvisa Record: 80145240358. Product Codes: 5M5509, 5M5509R, 5...

Manufacturer

Baxter Healthcare Corporation; BAXTER HOSPITALAR LTDA.