Events

Safety Alert for Steam Indicator Tape 1322

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by 3M Canada Company || 3M Health Care.

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
    R1705-195
  • Event Number
    2007DM-0001180
  • Date
    2017-05-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=85
  • 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 reports that it has detected as a result of internal tests that some rolls of tape do not adequately develop the correct standard visual color once the process of steam sterilization is completed, which can be interpreted as a failure in the sterilization process, leading to that they must be repeat the sterilization processes on the loads.

Device

Steam Indicator Tape 1322
  • Model / Serial
  • Product Description
    Use the steam indicator tape to demonstrate that the packages taken to steam sterilization processes have been exposed to the process and to distinguish between processed and unprocessed packaging.
  • Manufacturer
    3M Canada Company || 3M Health Care

Manufacturer

3M Canada Company || 3M Health Care
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    NIDFSINVIMA