Events

Safety Alert for HEMODIALIZERS. SERIES A15, A18, A22, (237015, 237018, 237022); AF150, AF180, AF220 (238015, 238018, 238022)

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

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
    117
  • Date
    2001-10-24
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The hemodializers were associated with a series of deaths in spain, croatia and the united states. the series has the same types of fibers and were manufactured by althin medical ab, which baxter purchased in march 2000. baxter started a preventive removal through correspondence sent on 24 october 2001. the manufacturer put the alert, and the information on current studies, on the internet http://www.Baxter.Com/customers/products_svcs/renal_therapies/recall/althanerecall.Doc.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE BAXTER LETTER OF 24 OCTOBER 2001, OR CHECK THE INTERNET HTTP://WWW.BAXTER.COM/CUSTOMERS/PRODUCTS_SVCS/RENAL_THERAPIES/RECALL/ALTHANERECALL.DOC. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. DO NOT USE THESE PRODUCTS! COMMUNICATE WITH YOUR BAXTER REPRESENTATIVE FOR THE AGENDA AND OPERATION OF REPLACING HEMODIALIZERS FROM SERIES TO OTHER BAXTER PRODUCTS. FOR FURTHER INFORMATION, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH BAXTER CONSUMER SERVICE IN THE UNITED STATES BY PHONE 1 (508) 261-8000.

Device

HEMODIALIZERS. SERIES A15, A18, A22, (237015, 237018, 237022); AF150, AF180, AF220 (238015, 23801...

Manufacturer

BAXTER INTERNATIONAL, INC.
  • Source
    ANVSANVISA