Events

Safety Alert for 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).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BAXTER HEALTHCARE CORPORATION; BAXTER HOSPITALAR LTDA..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1293
  • Date
    2013-09-13
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Claims related to infusion flow velocity greater than those intended for this type of device (elastomeric infusor).
  • Action
    Baxter has issued Safety Alert for its customers, alerting to the importance of following the instructions of use of the product. See attached details.

Device

BAXTER INFUSORS. ANVISA Register No. 10068390348. Products under risk: all lots for the last 3 ye...

Manufacturer

BAXTER HEALTHCARE CORPORATION; BAXTER HOSPITALAR LTDA.