Events

Recall of TEGO CATHETER CONNECTOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ICU MEDICAL INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35222
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    There is the potential risk of leaking with certain tego connector devices. the potential for leakage could exist when the tego is connected to the dialysis tubing during the hemodialysis treatment and may lead to blood loss.

Device

TEGO CATHETER CONNECTOR
  • Model / Serial
    Model Catalog: D1000 (Lot serial: 3261516); Model Catalog: D1000 (Lot serial: 3275467); Model Catalog: D1000 (Lot serial: 3239841); Model Catalog: D1000 (Lot serial: 3239848); Model Catalog: D1000 (Lot serial: 3260656); Model Catalog: D1000 (Lot serial: 3244558); Model Catalog: D1000 (Lot serial: 3244560); Model Catalog: D1000 (Lot serial: 3246196); Model Catalog: D1000 (Lot serial: 3255850); Model Catalog: D1000 (Lot serial: 3244023)
  • Product Description
    Tego Catheter Connector
  • Manufacturer
    ICU MEDICAL INC.

Manufacturer

ICU MEDICAL INC.
  • Manufacturer Address
    SAN CLEMENTE
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    HC