Recall of Device Recall Colleague, Colleague CX and CXE Volumetric Infusion Pumps

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 1
  • 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
    Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the colleague infusion pumps.
  • Action
    Baxter Healthcare Corporation sent an "Urgent Device Correction" letter dated January 23, 2009 to all Colleague Infusion Pump customers, to the attention of the Vice President of Nursing with copies to the Chief Operating Officer, Director of Biomedical Engineering and Director of Risk Management to advise them of failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages associated with the Colleague pumps. The letters listed the failure codes involved that lead to an interruption of therapy which could lead to serious injury and/or death; advised institutions to have contingency plans to verify that back-up pumps are available; and provided steps for addressing an interruption of therapy with any failure code. The letters also provided information about the hazards associated with improper cleaning of the pumps and instructions for addressing damaged battery messages. Customers were instructed to complete the attached Customer Reply Form acknowledging receipt of the letter and fax it to 888-569-1585. Direct questions to your local Baxter Representative or to Baxter Global Technical Services by calling 1-800-843-7867, Prompt 2, between 7AM and 5 PM Central Standard Time (CST).


  • Model / Serial
    All product numbers and all serial numbers.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, India, Ireland, Israel, Italy, Jamaica, Korea, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, United Kingdom and Venezuela.
  • Product Description
    Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product Codes: 2M8151, 2M8161, 2M9161, DNM8151, DNM9161, BRM8151, BRM8151T, BRM8151RT, PNM8151, PNM8151T, PNM8151RT, CNM8151, FKM8151, GNM8151, HNM8151, TRM8151 and WNM8151. || Electronic infusion pumps are indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
  • Manufacturer


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