Events

Safety Alert for reducing valves for medical gases GCE

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by GCE, S.R.O.

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
    R1508-419
  • Event Number
    2013DM-0010713
  • Date
    2015-08-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=172
  • 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 states that it has detected a wrong flow rate scale for values corresponding to 7 and 9 l / min, leading to confusions and poor regulation of the flow required by the patient.

Device

reducing valves for medical gases GCE
  • Model / Serial
    GCE150808-2 lots 0721037, 0721038, 0721039, 0721054, 0721065, 0721066, 0727018 and 0721049
  • Product Description
    Medical device used for the regulation of medical gases at a safe working pressure, intended to be used in pulmonary respiratory care services.
  • Manufacturer
    GCE, S.R.O

Manufacturer

GCE, S.R.O