Alerta De Seguridad para Trade name: Accessories for Liquor System ###. Technical Name: Infusion Port Catheter ###. ANVISA registration number: 10175060023 ###. Risk Class: IV (Maximum Risk) ###. Affected Model: ###. Batch numbers affected: AUTO087510 / 515, AUTO084109 / 240, AUTO088695 / 635, AUTO087642 / 526, AUTO088287 / 589, AUTO087772 / 561, AUTO088695 / 632

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.

The company emphasizes that there is no need for additional recommendations beyond those contained in the Instructions for Use of the product once the technical, manufacturing and validity characteristics of the product have been maintained. The measure taken by the company was the immediate blocking of sales and recall of the product as soon as it was found that the registration of the product had expired. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link