Events

Safety Alert for Hypodermic syringe with or without needle Alfa Safe

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Jiangsu Kanghua Medical Equipment Co., Ltd || Shandong Yixing Medical Devices || Xuyi Webest Medical Product Co. Ltda || Jiangsu Suyun Medical Materials Co., Ltd || Shandong Hapool Medical Tecnology. Co Ltd (T.M.H.S. Co Ltd) || Changzhou Huichun Medical Equipment 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
    R1707-307
  • Event Number
    2008DM-0001797
  • Date
    2017-07-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=77
  • 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 has detected quality failures of the referenced device, since at the moment of joining the needle with the syringe this fracture, including this condition has been evidenced before use, leading to possible delays in the procedures and adverse incidents with the patients.

Device

Hypodermic syringe with or without needle Alfa Safe

Manufacturer

Jiangsu Kanghua Medical Equipment Co., Ltd || Shandong Yixing Medical Devices || Xuyi Webest Medi...
  • Source
    NIDFSINVIMA