Implanted Infusion Device with Multi-Dose Reservoir /// Technical Name: Catheter with Infusion Port /// ANVISA Registration Number: 10175060017 /// Risk Class: IV - Maximum Risk /// Model Affected: 09039303 - Sectional Implanted Infusion Device with Multi-Dose Reservoir Affected Lot Numbers: See Distribution Map 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.

Suspend the marketing and use of the product. Products remaining on the market should be segregated and returned to the manufacturer. ## UPDATE # Field action closure: 12/12/2016. According to the report sent by the company, the products collected from customers and those that were in the company's stock were decharacterized. ### UPDATED ON 8/16/2017. The reason for the notification was discontinuation of the manufacture of regularized product. This situation does not constitute a motivation for field action, under the terms of RDC No. 23/2012.