Events

Safety Alert for Nebulizer kit

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

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
    R1601-35
  • Event Number
    2008DM-0002053
  • Date
    2016-01-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=160
  • 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 an error in the manufacture of a part of the component, compromising its ability to produce the atomization or nebulization of the medication supplied, saline or water contained in the nebulization unit, therefore the therapy planned for the patient will be affected, leading to potentially present adverse events on patients.

Device

Nebulizer kit
  • Model / Serial
    LM-86-772 and LM-86-777, lots 106285, 108968, 109162, 106286 and 108709.
  • Product Description
    Nebulizers are used to provide medications in aerosol form. The most common is the dilating bronchus, but steroids and antibiotics are provided under this route. These medications are used to open the airways of respiration.
  • Manufacturer
    Unomedical. Inc.

Manufacturer

Unomedical. Inc.