Events

Safety Alert for COSEAL 2ml and COSEAL 4ml. Registration Anvisa 80145240375. Lots under risk: COSEAL 2ml: HA130719 and HA140448; COSEAL 4ml: HA130322, HA130637, HA130721 and HA130919.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 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
    1409
  • Date
    2014-08-11
  • 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 product may exhibit reduced effectiveness due to failure to form the hydrogel, or even a hydrogel with mechanical resistance. If the product fails to form hydrogel or the hydrogel formed has an inappropriate (mechanical resistance) during a surgical procedure, the surgeon should use a new product kit or adopt an alternative surgical method. Additional information at http://portal.anvisa.gov.br/wps/wcm/connect/29102a80451087f1936fb7c2afb947e8/Message+of+Alerta_VENDA.pdf?MOD=AJPERES #### UPDATED ON 08/18/2017, the documentations of the action field sent by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Reason
    The effectiveness of the product may be compromised, given that tests carried out by the company have detected results below the specifications regarding the validity of the product.
  • Action
    BAXTER HOSPITALAR LTDA is collecting the product (affected batches described above). Do not use the product at risk and identify the hazardous units in your stock, segregate them and contact BAXTER or distributor for return purposes. For details on how to proceed, check additional information in the Alert Message posted by the company: http://portal.anvisa.gov.br/wps/wcm/connect/29102a80451087f1936fb7c2afb947e8/Messagem+de+Alerta_VENDA.pdf?MOD=AJPERES

Device

COSEAL 2ml and COSEAL 4ml. Registration Anvisa 80145240375. Lots under risk: COSEAL 2ml: HA130719...

Manufacturer

BAXTER HOSPITALAR LTDA.