Events

Safety Alert for Capillary Dialyzer H SERIES

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Nipro Corporation, Odate Plant.

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
    R1603-127
  • Event Number
    2009DM-0004649
  • Date
    2016-03-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=149
  • 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 identified a printing error on the expiration date which appears as 2015-08 when it should be 2018-08, since the batch was manufactured on september 6, 2015, leading to potentially confusions on the part of the users of the device. doctor.

Device

Capillary Dialyzer H SERIES
  • Model / Serial
    ELISIO 19H, lot 15I06AHA.
  • Product Description
    To remove toxic substances and excess water from the blood in patients with chronic or acute renal failure, when the dialysis is prescribed by a doctor.
  • Manufacturer
    Nipro Corporation, Odate Plant

Manufacturer

Nipro Corporation, Odate Plant