Events

Recall of FRENCH COLLEAGUE CXE VOLUMETRIC 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
    106988
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-18
  • 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 has determined that there is a potential soldering defect with a single component identified on a limited number of uim pcba (user interface module printed circuit board assembly) received from their pcba supplier/manufacturer. this issue is limited to the colleague pump serial numbers listed. this soldering defect could lead to a delay or interruption of therapy.

Device

FRENCH COLLEAGUE CXE VOLUMETRIC PUMP
  • Model / Serial
    Model Catalog: DNM9161 (Lot serial: 20110002JF); Model Catalog: DNM9161 (Lot serial: 20110004JF); Model Catalog: DNM9161 (Lot serial: 20110005JF); Model Catalog: DNM9161 (Lot serial: 20110007JF); Model Catalog: DNM9161 (Lot serial: 20110010JF); Model Catalog: DNM9161 (Lot serial: 20110001JF)
  • Product Description
    COLLEAGUE VOLUMETRIC INFUSION PUMP
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION