Events

Safety Alert for Disposable Syringe With and Without Needle

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

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
    R1606-270
  • Event Number
    2010DM-0005653
  • Date
    2016-06-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • 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
    It has been detected that in the labeling made in the factory, there is an error in the address of the importer printed on the packaging of the product, which can lead to the presence of potentially confusions in the opaque users and in contravention of the marketing requirements established normatively.

Device

Disposable Syringe With and Without Needle
  • Model / Serial
    SYRINGE 1,3 and 20 ml, lot 150408.
  • Product Description
    For main line, hypodermic or distribute and add medicines.
  • Manufacturer
    Kenxin International Co. Ltda.

Manufacturer

Kenxin International Co. Ltda.
  • Source
    NIDFSINVIMA