Events

Safety Alert for Low Temperature Sterilization System AMSCO

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Steris Mexico, S, De R.L. De C.V..

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
    I1607-281
  • Event Number
    2009DM-0003595
  • Date
    2016-07-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=131
  • 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 informs that it has detected that the correct date may not appear on february 29, 2016, its functional characteristics and operations cycles will always work correctly, which could lead to confusions of the users.

Device

Low Temperature Sterilization System AMSCO
  • Model / Serial
    V- PRO 1, V PRO MAX and V- PRO 1 PLUS, manufactured after January 1, 2014.
  • Product Description
    Terminal sterilization of reusable medical devices made of metal and not metal, cleaned, rinsed and dried
  • Manufacturer
    Steris Mexico, S, De R.L. De C.V.

Manufacturer

Steris Mexico, S, De R.L. De C.V.
  • Manufacturer Parent Company (2017)
    Steris plc
  • Source
    NIDFSINVIMA