Alerta De Seguridad para CATHETER VENOUS CENTRAL MULTI LUMENS - Registered in Anvisa under the number 10216830011 - Model DUPLO LUMEN 4FR X 13cm - RF lot 0087800.

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 collected parts will remain segregated until Arrow International, a foreign manufacturer responsible for the product, sends the final conclusion investigation report and the process is properly completed, when other measures may be taken as necessary. Due to the traceability in the company's Customer Service (SAC), only 03 complaints regarding this lot number were registered. Gabmed provided training to these Hospitals on the correct insertion technique and on reading the instructions for use of the product. Anvisa is following this field action.