Alerte De Sécurité sur Product name: Catheter Centimetrate Technical name: Catheter ANVISA registration number: 10212990193 Hazard class: IV Target group: NR5.0-35-100-P-10S-PIG-CSG-20

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.

Analyze whether these recalled items are still physically in your inventory, then the items should be immediately segregated; Contact E. Tamussino & Cia Ltda so that we can align the return of these catheters; Circulate the Recall Notice internally for all interested / affected parties; Inform E.Tamussino if any of the devices mentioned in this notice have been distributed to other organizations. Please provide contact details so that E.Tamussino can inform recipients accordingly. If you are a Distributor, please note that you are responsible for notifying your affected customers. 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