Alerte De Sécurité sur Trade name: ONCONTROL POWERED BONE ACCESS AND BONE LESION BIOPSY SYSTEM. Technical Name: Bone Marrow Collection and Aspiration Kit. ANVISA registration number: 80117580215. Class of risk: II. Model Affected: 9461 OnControl Coaxial Tray, 10GA x 152MM / 12GA x 197MM; 9462 OnControl Coaxial Tray, 11GA x 152MM / 13GA x 197MM ;. 9463 OnControl Coaxial Tray, 10GA x 102MM / 12GA x 147MM ;. 9464 OnControl Coaxial Tray, 11GA x 102MM / 13GA x 147MM ;. 9465 OnControl Coaxial Tray, 10GA x 60MM / 12GA x 105MM ;. 9466 OnControl Coaxial Tray, 11GA x 60MM / 13GA x 105MM. Affected Model Number: 9461 OnControl Coaxial Tray, 10GA x 152MM / 12GA x 197MM -Lots: 014615, 015399, 13686. Affected Model: 9462 OnControl Coaxial Tray, 11GA x 152MM / 13GA x 197MM -Lots: 013251, 012580S . Model Affected: 9463 OnControl Coaxial Tray, 11GA x 102MM / 13GA x 147MM -Lots: 14453,014618, 015269, 014025. / Model affected: 9465 OnControl Coaxial Tray, 10GA x 60MM / 12GA x 105MM- Lots: 014321S Model Affected: 9466 OnControl Coaxial Tray, 11GA x 60MM / 13GA x 105MM -Lote: 012685S

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 Additional information: - Date of identification of the problem by the company: 11/18/2016 - Date of notification notice to Anvisa: 07/11/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "