Alerta De Seguridad para Trade name: Revolve System. Technical Name: Drainage System. ANVISA registration number: 80624960022. Risk class: II. Affected Model: RV0001WW. Serial numbers affected :. Model RV0001WW LOT: 10841. Model RV0001WW LOT: 11218

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.

Customers are required to perform the following actions: 1. Inspect your stock immediately count and segregate all Revolve System units that are in your possession to prevent its use. 2. If you have resold or distributed this product, please identify your recipients and send them this notice, with instructions that all available product in your inventory should be segregated to prevent its use. 3. Complete the response form that is attached to this notification, including your contact information. Return the completed form immediately, through one of the following available channels (e-mail / mail). 4. If you have stock in your inventory units to be collected, we will contact you to pick up the product. 5. This voluntary recall is being conducted to reach the end user. To ensure that we locate all affected product units, we ask for your support in returning the completed response form even if you do not have affected units in your stock. 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: 05/09/2017 - Date of notification notice to Anvisa: 09/15/2017 The company holding the record of 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. (...) "