Events

Safety Alert for CATETER UMBILICAL GMI Technical Name: CATETER UMBILICAL Registration Number ANVISA: 80423540023 Hazard Class: III Model Affected: 544-25 / 544-35 / 544-40 / 544-50 / 544-60

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Gabisa Medical International LTDA EPP.

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
    2200
  • Date
    2016-12-18
  • 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
    1. Check the integrity of the packaging 2. Check the sterilization and expiration dates, do not use after the expiration date. 3. Keep the product in a cool place and protected from the sun. 4. Observe the distance marked on the catheter for each case.
  • Reason
    The umbilical catheter is demarcated every 4 to 24 cm along its length with stitches, this marking hinders the use of the product by the user team (doctors / nurses).
  • Action
    Field Action Code triggered under the responsibility of the company Gabisa Medical International LTDA EPP. Company will make improvements to product usability.

Device

CATETER UMBILICAL GMI Technical Name: CATETER UMBILICAL Registration Number ANVISA: 80423540023 H...

Manufacturer

Gabisa Medical International LTDA EPP