Safety Alert for Trade Name: Bardport Port Fully Implantable in Titanium and Silicon; Fully Implantable Bardport in Plastic and Silicone; Port Implanted X-Port Isp with Silicone Catheter and Peel-Apart Bard Introducer Kit; Powerport Chronoflex Open End Mri; Powerport Catheter Groshong Valvular Mri. Technical Name: Infusion Catheter; Infusion Port Catheter. ANVISA registration number :. 80689090126; 80689090128; 80689090136; 80689090103; 80689090105. Hazard Class: IV. Affected model: Titanium Ports (base diameter: 31.7 mm, height: 14.5 mm, weight: 15.4 g); Port Titanium Dome (base diameter: 27.2 mm, height: 15 mm, weight: 7.9 g); MRI Ports Low Profile (base diameter: 24.8 mm, height: 10 mm, weight: 3.2 g); connectable; 8 Fr - Polyurethane catheter without suture plug; 8F MRI without suture plug, single lumen .. Serial Numbers Affected: Code Lot Number: 0602240 REBT0050; 0602850 REBT0345; 0603870 REBT2330; 0607555 REBT2153; 0607555 REBV1315; 8808061 REBU0499; 8808561 REBU1200

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.

The following steps should be taken: 1) Check your entire stock for the product / lot code combinations affected by this recall. 2) If you have distributed any batch number / code, please contact your customer immediately and alert him / her to the recall by requesting that you return the affected product to Bard Brasil Indústria e Comércio de Produtos para Saúde Ltda. 3) Segregate any identified product from your stock. 4) Once the product affected by this collection is identified and withdrawn from its stock; fill out the form attached to the Letter to the Client. Report exactly the quantities and lot numbers of each product of this recall that you have in stock. 5) If you have used any listed product, complete the recall verification form stating that no product will return. If you have any questions, please contact the company: e-mail Sao-tecnovigilancia@crbard.com. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). 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 Complementary Information: - Date of identification of the problem by the company: 04/23/2018 - Date of notification notice to Anvisa: 05/21/2018 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. (...)