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
    31899
  • Event Risk Class
    III
  • Event Initiated Date
    2014-12-18
  • 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 is issuing an important product information for the colleague pump (p1.7a) to remind users to reset the manual tube release (mtr) when it is left in the open position. users that do not follow the labeled instructions for resetting the mtr prior to use will be unable to power on the device. this has the potential to lead to a delay in therapy as the device will not power on.

Device

COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP
  • Model / Serial
    Model Catalog: 2M91617A (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM91637A (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM91617A (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M91637A (Lot serial: >1000 NUMBERS CONTACT MFR)
  • Product Description
    COLLEAGUE CXE COLOR PUMP
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION