Events

Alerte De Sécurité sur HEMODIALIZERS. SERIES A15, A18, A22, (237015, 237018, 237022); AF150, AF180, AF220 (238015, 238018, 238022)

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par BAXTER INTERNATIONAL, INC..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    118
  • Date
    2001-10-24
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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