Events

Safety Alert for Circuits for Anesthesia

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

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
    R1410-397
  • Event Number
    2008DM-0002942
  • Date
    2014-10-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=195
  • 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 determined that the ends of the devices can break before and during their use and should be replaced immediately, leading to the potential occurrence of adverse events on the patient.

Device

Circuits for Anesthesia
  • Model / Serial
    313901, 353801, 353811, 353812H, 3653900, 353901 and 353911, specific lots
  • Product Description
    Interphase in the mechanical ventilation procedure for patients who undergo procedures in which they must be anesthetized.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical