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
    20731
  • Event Risk Class
    II
  • Event Initiated Date
    2008-11-20
  • 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
    Damaged batteries 2 specific sequence of events lead to invalid infusion register state faults in internal communications of pump pump may short circuit due to fluid ingress or compromised insulation.

Device

COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP
  • Model / Serial
    Model Catalog: 2M9161 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: DNM9163 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: DNM 8151 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 2M8161 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 2M8153 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 2M9163 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: DNM 8153 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 2M8151 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 2M8163 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    COLLEAGUE GUARDIAN ENHANCED CXE PUMP
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION