Events

Safety Alert for Titanium adapter for peritoneal dialysis catheter, equipment 6 "transfer with long-term twist-clamp and pre kit CAPD-SDD ", all lots

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Baxter Hospitalar 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
    A1502-56
  • Event Number
    2010DM-001287-R2
  • Date
    2015-02-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=186
  • 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 has identified the need to perform a strict follow-up of patients undergoing peritoneal dialysis, due to the possibility of presenting a situation of dealergia to iodine, as a consequence of the use of any of the related medical devices, which may lead to the occurrence of potentially adverse events. the patient.

Device

Titanium adapter for peritoneal dialysis catheter, equipment 6 "transfer with long-term twist-cla...
  • Model / Serial
    CAPD-SDD, all batches.
  • Product Description
    To be used in a peritoneal dialysis system.
  • Manufacturer
    Baxter Hospitalar Ltda.

Manufacturer

Baxter Hospitalar Ltda.