Events

Recall of COLLEAGUE GUARDIAN ENHANCED 3 CXE COLOR PUMP

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

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
    151665
  • Event Risk Class
    II
  • Event Initiated Date
    2008-11-14
  • 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
    User instructions for colleague triple channel pumps utilizing specific software does not clearly describe the correct operation for programming a piggyback infusion when in dose or guradian feature dose modes.

Device

COLLEAGUE GUARDIAN ENHANCED 3 CXE COLOR PUMP
  • Model / Serial
    Model Catalog: 2M9163 (Lot serial: >1000 NUMBERS); Model Catalog: 2M9163 (Lot serial: CONTACT); Model Catalog: 2M9163 (Lot serial: MANUFACTURER); Model Catalog: 2M8153 (Lot serial: >100 NUMBERS); Model Catalog: 2M8163 (Lot serial: >100 NUMBERS); Model Catalog: DNM 8153 (Lot serial: >100 NUMBERS); Model Catalog: 2M8153 (Lot serial: CONTACT); Model Catalog: 2M8163 (Lot serial: CONTACT); Model Catalog: DNM 8153 (Lot serial: CONTACT); Model Catalog: 2M8153 (Lot serial: MANUFACTURER); Model Catalog: DNM 8153 (Lot serial: MANUFACTURER); Model Catalog: 2M8163 (Lot serial: MANUFACTURER); Model Catalog: DNM9163 (Lot serial: >100 NUMBERS); Model Catalog: DNM9163 (Lot serial: CONTACT); Model Catalog: DNM9163 (Lot serial: MANUFACTURER)
  • Product Description
    COLLEAGUE GUARDIAN ENHANCED 3 CXE PUMP
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION