Events

Safety Alert for Mask for Oxygen Supply KYOLING

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

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
    R1710-500
  • Event Number
    2017DM-0000761-R1
  • Date
    2017-10-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=66
  • 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 importer reports that the diameters of the oxygen dials have a diameter greater than normal, this accessory of the device is difficult to exchange, leading to possible delays in the procedures or adverse events on patients.

Device

Mask for Oxygen Supply KYOLING
  • Model / Serial
    HX.O02, lots 32611504, 32611602, 32611607, 32611612
  • Product Description
    This sanitary registry covers the models HX.O01, HXO02, HX.O04 in sizes XXL, XL, L, M, S, XS. Associated labels conradicated no. 2017031444 of March 08, 2017 with updated and additional information. Authorization of labels in the sense of updating in the field of "color of the diluent" the distribution of the colors that is found on the label of the mask for oxygen supply ventury, by means of 2017121480
  • Manufacturer
    Hangzhou Jinli Medical Appliances Co., Ltd

Manufacturer

Hangzhou Jinli Medical Appliances Co., Ltd
  • Source
    NIDFSINVIMA