Events

Safety Alert for Nutrisafe 2 probes

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Laboratoires Pharmaceutiques Vygon..

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
    R1601-2
  • Event Number
    2009DM-0004840
  • Date
    2016-01-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=162
  • 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 reports that it has detected defects in lanumeration of some devices that have been printed and incorrectly marked, however it can be detected visually, leading to potentially adverse events on patients or delays in the procedure.

Device

Nutrisafe 2 probes
  • Model / Serial
    0363062, lot 200715FE
  • Product Description
    Enteral feeding of newborn, infant and child in resuscitation, neonatology and pediatrics.
  • Manufacturer
    Laboratoires Pharmaceutiques Vygon.

Manufacturer

Laboratoires Pharmaceutiques Vygon.