Events

Safety Alert for HomeChoice and HomeChoice Pro

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

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
    I1411-474
  • Event Number
    2008EBC-0002066
  • Date
    2014-11-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=192
  • 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 it is carrying out the update of the additional warnings and precautions in the labeling of the referenced products such as 5c4471, 5c4471r, 5c4474, 5c8310, 5c8310r, r5c8320, t5c4441 and t5c8300, these considerations could affect the safety of the patients, leading to their being potentiallypresent serious adverse events on the patient.

Device

HomeChoice and HomeChoice Pro

Manufacturer

Baxter Healthcare Corporation || Baxter Healthcare S.A.