Alerta De Seguridad para Millennium Lightining High Speed ​​Probe - 25 Gauge (Code nº 5825) Anvisa Registration nº 10196150071.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bausch & Lomb do Brasil.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    1. Bausch & Lomb do Brasil voluntarily interrupted all distribution of the product identified by Code CX 5825 in the Brazilian market on 01/02/2007, 2. Physically segregated all the probes in its stock in order to guarantee the non-distribution of the product; 3. Prepared and distributed an explanatory letter to all clients who received the probe - in this letter requests that the probes CX 5825 be sent immediately to the Bausch & Lomb unit in the city of Porto Alegre - RS. 2. On August 4, 2007, we received information on the collection of the product, with clarification on the quantity of the product marketed and collected on the Brazilian market. On 08/29/2007, we received, through Bausch & Lomb, a document from Polimax - CNPJ 04.949.701 / 0001-22, describing and attesting the process of destruction of units of the product to be recalled. On September 21, 2007, through Technical Report No. 26/2007 - UTVIG / NUVIG / ANVISA, the mentioned dossier was filed, with a view to finalizing the actions of this recall.
  • Causa
    Unintentional contact of the internal needle cutting tip with the outer shell of the unit causes the probe to break. the product lots distributed in the brazilian market were: t5578, t6373, t6501, t6782, t7105.
  • Acción
    Bausch & Lomb advises healthcare professionals to immediately check their stock for the indicated product: Millennium Lightning High Speed ​​Probe - 25 G (Code no. CX 5825) and emphasizes NOT TO USE THE AFFECTED PRODUCT.


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