Alerte De Sécurité sur Trade Name: Transfer Kit for Exactamix. Technical Name: Transfer Kit for Exactamix. ANVISA registration number: 80145240403. Class of Risk: II. Affected Model: H938173 | H938174 | H938175 | H938176. Serial numbers affected: 802385 | 802279 | 802281 | 802284

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.

Manufacturer's Recommendations: 1. Locate and segregate all batches of affected products within your institution. The product code and batch number can be found on the products or in the shipping boxes. 2. If you purchased this product directly from the company holding the registration, fill out the customer response form and send to the company via e-mail to faleconosco@baxter.com or via fax to (XX) 11 5635-0106 or to 0800 012 5522, informing the quantity present in your stock, even if there is no remaining stock in your facility. The prompt return of the customer response form will confirm receipt of the notification and will prevent you from receiving the notice several times. 3. Once this is done, the company will contact you to arrange for return and credit. 4. If you distribute this product to other institutions or departments within your institution, please send a copy of that document to them. 5. If you are a reseller, wholesaler, distributor or original equipment manufacturer (OEM) distributing any affected product to other institutions, please conduct the collection at the customer level that you distributed the affected products. Then inform the company according to the procedure described in step 2. 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: 03/04/2018 - Date of notification notice to Anvisa: 05/10/2018 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. (...) "