Alerte De Sécurité sur LANCETAS SFL YELLOW 2.2X1.0mm - MICROTAINER BRAND SAFETY FLOW LANCETS BDLANCETA MICROTRAINER. II - MEDIUM RISK, Reg. ANVISA: 10033430270 - Lots: 2319394, 3069725, 3149410 and 3213535.

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 Becton Dickinson and Company.

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
    896
  • Date
    2007-11-27
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    Upon failure of the anti-reuse device, the lancet blade may be exposed during disposal. Note: manufacture of this product was discontinued in 2003. The last sale in Brazil occurred in 2004 and the registration of the product with ANVISA was valid until the year 2005. The product in question is not intended for home users, only hospitals and clinics According to the company there were no reported problems with the lots involved in Brazil and that the collection of this product 3 years after the closure of sales is preventive. For further information contact the BD Technical Center, through the Telephone. 0800.055.5654.// Update: On January 23, 2008 the company reported that 38 customers received the product and that all were informed of the recall, of which 24 stated they did not have any unit of the lots involved in stock. They also reported that this recall was released in the media (newspaper, radio and television) in November 2007.
  • Cause
    Limited number of reports of device-trigger device crash. access the lots: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2007/896.Pdf.
  • Action
    Voluntary pickup with mailing for all customers requesting that the use of the product be interrupted and the remaining quantities are returned to the company.

Manufacturer

  • Source
    ANVSANVISA