Events

Safety Alert for Millennium Lightining High Speed ​​Probe - 25 Gauge (Code nº 5825) Anvisa Registration nº 10196150071.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Bausch & Lomb do Brasil.

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
    854
  • Date
    2007-02-28
  • 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
    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.
  • Reason
    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.
  • Action
    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.

Device

Millennium Lightining High Speed ​​Probe - 25 Gauge (Code nº 5825) Anvisa Registration nº 1019615...

Manufacturer

Bausch & Lomb do Brasil
  • Source
    ANVSANVISA