Events

Safety Alert for Set for preparation and administration of chemotherapy

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

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
    I1403-109
  • Event Number
    2012DM-0008925
  • Date
    2014-03-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=207
  • 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 in the mentioned devices, they may present leaks at the level of the "y", leading to potentially adverse events occurring on the patient.

Device

Set for preparation and administration of chemotherapy
  • Model / Serial
  • Product Description
    The CHEMO-DRIVE chemotherapy preparation and administration set is a device whose indication for use is the preparation and administration of anti-blast drugs, which are administered to the patient by intravenous route. It is a completely closed, aseptic system that intrinsically makes the mixture of the diluent with the drugs in amounts established in the formulation and afterwards iv administration to the patient with total biosecurity. Because it is a closed system, the medical personnel never come into contact with the dangerous substances of the medica.Se is used for the preparation and administration of complete chemotherapies in a hospital or home environment with total security. Medications to be filled and administered have their sanitary registration.
  • Manufacturer
    CAIR LGL

Manufacturer

CAIR LGL
  • Manufacturer Parent Company (2017)
    Cair Lgl
  • Source
    NIDFSINVIMA