Events

Safety Alert for SPEEDICATH CH12 catheter

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Coloplast A/S.

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
    R1605-200
  • Event Number
    2011DM-0008213
  • Date
    2016-05-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=141
  • 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 that possibly the sterility of the referenced device is compromised by a problem in the manufacturing process, leading potentially to occur adverse events on patients.

Device

SPEEDICATH CH12 catheter
  • Model / Serial
    CH12-281120, lots 5071031, 5078045 and 5081635.
  • Product Description
    Catheter lubricated ready to use, single use, immersed in saline solution, conditioned in a sterile container that allows aseptic handling, reducing the risk ofinfection.
  • Manufacturer
    Coloplast A/S

Manufacturer

Coloplast A/S