Recall of Device Recall Colleague CX Volumetric Infusion Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    While the infusion pump was being serviced at the baxter service center, it was inadvertently routed to the packaging area before the final inspection.
  • Action
    Baxter telephoned the one customer on December 1, 2010, informing them that that an outgoing Quality Control Evaluation was not performed on their Colleague pump serial number 15030799CC during the last service. Since this was not conducted on this pump, the device may not function as designed and could lead to an interruption of therapy. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost. For questions regarding this recall call (800) 437-5176.


  • Model / Serial
    Product Code: 2M8161, serial number 15030799CC
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
  • Product Description
    Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161
  • Manufacturer


  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source