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

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.

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.