Events

Safety Alert for GOLDEN CARE Tracheotomy Cannula

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Hitec Medical Co. Ltd.

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
    R1711-534
  • Event Number
    2015DM-0013886
  • Date
    2017-11-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=64
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer informs that he has received the report of an adverse event that generated the doubling of the referenced device, reason for which after analyzing the possible causes has decided to preventively change the mold of conformation and modify the density of the material used, this situation could lead to that potential adverse events occur on patients.

Device

GOLDEN CARE Tracheotomy Cannula
  • Model / Serial
    GCA-HTC0570C, all lots
  • Product Description
    The tracheostomy tube is used in general anesthesia, intensive care and emergency medicine for the management of airways and mechanical ventilation. The tube is inserted into the patient's trachea through an incision in the trachea.
  • Manufacturer
    Hitec Medical Co. Ltd

Manufacturer

Hitec Medical Co. Ltd
  • Source
    NIDFSINVIMA