Events

Alerte De Sécurité sur Tubes, blood collection, Plasma Separator Tubes Vacutainer Plus 45 ml 13 x 100. catalog number: 367962; Number of lots: 1008353

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 BD Vacutainer Systems Div BD.

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
    331
  • Date
    2001-11-09
  • 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
    Some of the tubes above did not have the required amount of lithium heparin. the distributor started the removal by letter dated august 17, 2001.
  • Action
    Check out BD Vacutainer Systems has already contacted you. Identify and isolate all affected products in your inventory. For more information, contact your local representative or directly with BD Vacutainer Systems at (888) 237-2762 in the United States. ANVISA is interested in following if there was good collaboration of the distributor with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Device

Tubes, blood collection, Plasma Separator Tubes Vacutainer Plus 45 ml 13 x 100. catalog number: 3...

Manufacturer

BD Vacutainer Systems Div BD
  • Source
    ANVSANVISA