BAXTER EQUIPMENT FOR PACLITAXEL WITH AIR INPUT .. Class of Risk II. Anvisa Record: 10068390316. 의 안전성 경고

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.

Baxter Hospitalar Ltda has informed that it will collect specific batches of the product PACLITAXEL EQUIPMENT WITH AIR INLET, due to complaints from users regarding leakage during use. Equipment that has leaks should be kept in a sealed and quarantined container and gloves should be used to handle the material (due to the toxic potential of Paclitaxel). Anvisa's Technovigilance Unit is following up on this case. ######## Update (23/08/2007): Baxter Ltda has notified the Anvisa Technovigilance unit (UTVIG / NUVIG / ANVISA / MS) that closed the action of collecting the product EQUIPMENT FOR PACLITAXEL WITH AIR INPUT, presenting the documentation regarding the destruction of the product. According to the company, of the 24,285 units sold, 9,592 units were collected and destroyed.