Locking Titanium Adapter for Peritoneal Dialysis Catheter (Anvisa Registry # 10068390171); 6 "Transfer Kit with Long Stay Twist-Clamp (Anvisa Registration No. 10068390005); Prep Kit for CAPD-SDD (Anvisa Record 10068390336). 의 안전성 경고

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 will add a phrase in the instructions for use of the disconnection systems, warning that the product should not be used in patients with a known history of allergic reactions to iodine. Check full information in the alert message published by the company, available at: http://portal.anvisa.gov.br/wps/wcm/connect/99fa2e00472fc243aafebbbb1e455ac3/Carta+ao+Cliente.pdf?MOD=AJPERES