Events

Safety Alert for (1) A-11, (2) A-15, (3) A (1) A-11, (2) A-15, (3) A -18, (4) A-22, (5) AF-150, (6) AF-180, (7) AF-220, (8) AX-15, (9) AX-22; dialyzer with cellulose acetate fiber series A: (10) Altra Flux, (11) Altra Nova, (12) Altrex, Product codes: (1) 237011, 237311, 237511; (2) 237015, 237315, 237515; (3) 237018, 237318, 237518; (4) 237022; (5) 238015, 238515; (6) 238018, 238518; (7) 238022, 238522; (8) 239015; (9) 239022, 239522; (10 to 12) unidentified; number of lots: (1 to 9) all numbers, (10) 990904P6A1 to 011017P7A, (11) 990924P1D1 to 011019P4A, (12) 990929P6A1 to 000203P6A1; number of catalogs: (1 to 9) unidentified; (10 to 12) 100-416, 100-923, 700-098, 700-150

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
    385
  • Date
    2001-12-07
  • 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
    Ecri discussed the current baxter dialysis research on deaths in the united states and abroad. the fda recently issued additional information regarding this correction. in addition to the original models being corrected, baxter is withdrawing its a-11, ax-15 and ax-22 models as a precautionary measure, baxter is redoing the altra flux series a cellulose acetate , altra nova and altrex used in baxter a, af and ax series dialyzers.
  • Action
    Please verify receipt of the dated letter and response form dated October 18, 2001 from Baxter. Identify and isolate all affected products in your inventory. Baxter recommends that you immediately stop using any of the products mentioned above. Complete and return the response form to the following fax number (847) 270-5457. If you have distributed these dialyzers to other establishments, please send the correction letter and the response form to these units immediately. For more information, contact your local representative and visit http://www.baxter.com/customers/cust_svc/index.html to find links specific to your country. Baxter began corrections by telephone and by letter dated October 18, 2001.

Device

(1) A-11, (2) A-15, (3) A (1) A-11, (2) A-15, (3) A -18, (4) A-22, (5) AF-150, (6) AF-180, (7) AF...

Manufacturer

Baxter International Inc
  • Source
    ANVSANVISA