Alerta De Seguridad para Transfer Equipment for Automix - 2C0477

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 withdrawal from the market will cover all customers who have purchased the product in the last two years in order to ensure that all the product available on the market with the plastic packaging is withdrawn. The proposed period is based on the date on which the packaging was replaced, ie 2001, the year of revalidation of the product, at which time the sterilization method was also changed from ethylene oxide to gamma radiation. Make sure you have received a response form - referring to the May / 03 release. Complete and return to Baxter by fax 11-5694.8499. For more information contact Baxter Hospitalar Ltda, phone: 11-56948500 or your local representative.