Events

Recall of SYMBIQ INFUSION SYSTEM TWO-CHANNEL

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
    22556
  • Event Risk Class
    I
  • Event Initiated Date
    2010-04-26
  • 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
    1-increase frequency of white screen alarm code 2-potential unrestricted flow when set is removed from the pump. moreover the check flow stop alarm intended to warn users of free flow conditions may not consistently operate as intended and may not reliably provide appropriate warning. 3-reports of symbiq pump not detecting air in line.

Device

SYMBIQ INFUSION SYSTEM TWO-CHANNEL

Manufacturer

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