Events

Safety Alert for heparinized syringes for arterial blood sampling Carefusion

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Carefusion || Productos Urólogos de México, S.A. De C.V. || Carefusion 211, Inc Dba Carefusion.

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
    I1608-324
  • Event Number
    2016DM-0014975
  • Date
    2016-08-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=127
  • 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 identified that the referenced devices do not contain the closing and blocking component, exposing the needle contaminated with blood, leading to the occurrence of possible adverse events on the users.

Device

heparinized syringes for arterial blood sampling Carefusion

Manufacturer

Carefusion || Productos Urólogos de México, S.A. De C.V. || Carefusion 211, Inc Dba Carefusion