Events

Safety Alert for Disposable syringes Radiometer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Radiometer Medical A.P.S..

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
    R1801-72
  • Event Number
    2003V-0001817-R1
  • Date
    2018-01-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=57
  • 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 has detected that the needle may be attached incorrectly to the body of the syringe, in the worst case it could cause the needle to detach, if the needle is separated from the body of the syringe after being removed from a patient, there is risk of an accident with exposure to blood, this situation could lead to possible adverse events on patients and / or users.

Device

Disposable syringes Radiometer

Manufacturer

Radiometer Medical A.P.S.