Alerta De Seguridad para BAXTER INFUSORS. Anvisa Registration n ° 10068390348. Models: 2C1071KJP and 2C1075KJP. Lots under risk in Brazil: 09B024, 09B078, 09D026, 09D085, 09E052, 09H070, 09N028, 09N029 and 09N027.

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 detected increased leakage complaints between the lid and the luer of the product. Corrective actions were then implemented to improve the fence between the lid and the Luer, which solved the problem according to the company. To ensure that no affected products remain in circulation, they are being collected. Leakage of the lid and distal luer may result in delayed or interrupted therapy, which may result in administration of a lower dose to the patient and need for medical intervention. As a result of the problem, delays or interruptions of therapy may result in the administration of a lower dose to the patient and the need for medical intervention. The potential damage of delayed or discontinued therapy and exposure to hazardous substances is considered to be serious. In addition, patients and health professionals are potentially at risk of harm from exposure to hazardous solutions, such as chemotherapeutic agents. Access the Letter to Clients disclosed by the company at: http://portal.anvisa.gov.br/wps/wcm/connect/fe6d4b0041499b1b94329fa8d08ea2d4/Carta_ao_cliente.pdf?MOD=AJPERES. #### UPDATE: Infusion models under risk have been inserted in the "Product Description" field. According to Baxter, the product in question has more than 20 models of registered infusers, but this field action covers only two models. #### 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.