Events

Safety Alert for Sterile and Non-sterile gauze sponges

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Zhejiang Shaoxing Yongfeng Surgical Dressing 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
    R1606-269
  • Event Number
    2006DM-000047
  • Date
    2016-06-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=135
  • 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 that the raw material of the gauze packaging, in this case the medical grade paper, does not present enough and necessary adhesion with the film, for this reason, when both (paper and film) are sealed, the result is unsello with a weak force and this, added to the weight of the gas, causes the product to open easily, compromising the sterility of the product, which can lead to potentially serious adverse events on the patients.

Device

Sterile and Non-sterile gauze sponges

Manufacturer

Zhejiang Shaoxing Yongfeng Surgical Dressing Co. Ltd
  • Source
    NIDFSINVIMA