Alerta De Seguridad para Trade Name: Percutaneous Access Set Aprima. ANVISA registration number: 10212990312. Technical name: Others for Medical-Hospital Consumption. Risk class: II - Medium Risk. Affected model: NPAS-104-HC-NT-U-SST. Batch numbers affected :. CODE DESCRIPTION LOT. G52965 NPAS-104-HC-NT-U-SST 5146406. G52965 NPAS-104-HC-NT-U-SST 5146407. G52965 NPAS-104-HC-NT-U-SST NS5469904. G52965 NPAS-104-HC-NT-U-SST NS5469905

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.

E.Tamussino, as registry holder and principal representative, hereby communicates to all its customers that manufacturer Cook Medical Inc. has initiated a global recall related to catheters with Beacon Tip technology. The recall action codes T10071-32, T10071-34, T10071-35, T10071-36, T10071-37, T10071-38, T11747-3, T11747-6, T11747-8 refer to the products listed in the appendix. Customer orientations: 1) Review the relationship of the affected products and confirm if these items are still physically in their inventory, then the items should be immediately segregated; 2) Contact E. Tamussino & Cia Ltda so that we can align the return of these catheters; 3) Circle this Recall Notice internally for all interested / affected parties; 4) Inform E.Tamussino if any of the devices mentioned in this notice have been distributed to other organizations. 5) Please provide contact details so that E.Tamussino can inform recipients accordingly. 6) If you are a Distributor, please note that you are responsible for notifying your affected customers. 7) Please fill out the form attached to the customer communication letter and send it by e-mail within 7 days from the receipt of this notice to the technical heads of the State for which you are served Contacts: Telephone for contact: ( 21) 3221-8570 larissa.costa@tamussino.com.br