Alerta De Seguridad para ESCOVAFLEX PVPI - SPONGE AND POLYETHYLENE BRUSH, 8X4CM DIMENSIONS, WITH 10ML SOLUTION - REGISTRATION 10342310031, LOTS 1078 E 085/12

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.

Considering the deviations verified, there is a possibility of loss of traceability of the product and problems for the aseptic opening. The manufacturing company has made changes to the procedures and the production process as a matter of urgency, a specific stamping machine has been acquired, resulting in a more precise control of the date and temperature of the datador, providing a clear impression (batch and date of manufacture). With respect to the picking, the company increased the sealing margin of the packaging, with procedures to avoid that failures occur in the process of "pecking". As for the partial detachment of the sponges, the company informs that it reinforced the sealing process of the same.