Alerta De Seguridad para Trade name: HEMOSTOP. Technical Name: Gingival Retractors and Hemostatic. ANVISA registration number: 10186370148. Risk class: II - Medium Risk. Affected batches: 1938021, 1938031, and 1962491

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.

If the customer receives the wrong barcode product, he must inform Dentsply that the barcode product will be made. The following actions will be taken: - Rework of the customer tags that have bought more than 50 units of Hemostop with the wrong barcode. This rework will be done by our business advisor. - Send a letter of communication of data to customers who buy less than 50 units to verify if they need some rework units. If there are affected customers, the labels will be replaced in dental by our business advisor. 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