Events

Safety Alert for Pressure regulators

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Baxter A.G. || Micromedics 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
    R1502-68
  • Event Number
    2008DM-0001647 ; 2011DM-0007165
  • Date
    2015-02-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • 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 reports that it is advancing the replacement of the regulators referenced by devices recently developed which allow a maximum depression control of 2.0 bar in accordance with the limits allowed for open surgery (2.0 bar) and delaparoscopy procedures (1.5 bar), higher operating pressures could lead to to generate adverse events on the patient.

Device

Pressure regulators
  • Model / Serial
    EASY SPRAY, DUPLOSPRAY MIS REGULATOR and TISSOMAT” codes 0600075, 1504275, 0600123, 0600032 and Z9501100999901.
  • Product Description
    This equipment is indicated to regulate the spraying of medical devices TISSUCOL and COSEAL.E s a non-sterile medical device, used for the application of fibrin sealants
  • Manufacturer
    Baxter A.G. || Micromedics Inc.

Manufacturer

Baxter A.G. || Micromedics Inc.
  • Source
    NIDFSINVIMA