Alerta De Seguridad para Trade name: OnControl Biopsy System Needle Trays //. Technical Name: Bone Marrow Biopsy Kit //. ANVISA registration number: 80117580255 //. Risk class: II - Medium Risk //. Affected Model: 9411 OnControl Biopsy System Needle Trays, 152MM; 9408 OnControl Biopsy System Needle Trays, 102MM //. Lots Affected: Model 9411 - OnControl Biopsy System Needle Trays, 152mm - Lots 014617, 014310, 013468, 14197 // Model 9408 - OnControl Biopsy System Needle Trays, 102mm - Lots 014569, 014308, 013257

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.

1. If there are products in stock, immediately discontinue use of the product and segregate them in the quarantine and request recall. 2.To return the product, complete the recall recall form and send it to the distributor or via email recalls @ teleflex. with. This will allow you to identify the number of products in stock for return. A representative of the distributor who has carried out the commercialization of this product will contact you and guide you in the best way to return these products. 3. If you do not have any quantity of the affected product in stock, please complete the recall form, forward it to the distributor or via e-mail to recalls@teleflex.com. This will confirm that you have received this collection notice. 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