Events

Recall of COLLEAGUE GUARDIAN ENHANCED 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
    30851
  • Event Risk Class
    II
  • Event Initiated Date
    2013-09-19
  • 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
    Baxter will commence a remediation strategy whereby all current colleague pump customers will be provided with a newly manufactured colleague p1.7a pump software version 8.01.90 (en) or 8.11.90 (fr) in exchange for each existing pump with an earlier software version. this remediation is being conducted to correct pump issues previously communicated on january 29 2009 (recall number 45280 baxter reference 2008fca18) and to provide other software and mechanical upgrades.

Device

COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP
  • Model / Serial
    Model Catalog: 2M9161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM 8153 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8153K (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8153 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M9163 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8163 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151K (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM 8151 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM9161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM9163 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Product Description
    COLLEAGUE GUARDIAN ENHANCE CXE COLOR
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION