Alerta De Seguridad para BAXTER INFUSORS. ANVISA Register No. 10068390348. Products under risk: all lots for the last 3 years (codes: 2C1071KJP, 2C1075KJP, 2C1080KJP, 2C1082KJ, 2C1156KP, 2C1163KP, 2C1087KP, 2C1008KP, 2C1009KP and 2C1954KJP).

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 production plant received 225 complaints related to the infusion rate greater than that intended, involving the elastomeric systems in question. According to the company, health care providers must continue to follow the instructions for use of the product to avoid the occurrence of changes in infusion rates - see attached details. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.