Recall of Device Recall Colleague and Colleague CX 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
    The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11.
  • Action
    Baxter sent the 3/15/05 Urgent Device Correction letter to all Colleague Infusion Pump customers to alert them of actions they can take in the short-term to address specific user actions and several error codes in the event of an occurrence, which could lead to serious adverse health consequences if a patient is receiving life-sustaining medication at the time of the pump failure. Users were urged to verify that the pump is infusing after pressing the Start key. If the hospital uses the external monitoring capabilities of the pump for a nurse call or remote pump monitoring, they were requested to ensure that the external computer or monitoring system does not send data to the pump, and that the pump is powered off when connecting and disconnecting the cable to the DB9 port to avoid a 16:336 failure code. If a 16:336 failure occurs the user is advised to power the pump off and back on again. The users were advised to have a contigency plan to mitigate any disruptions of infusions of life sustaining drugs if failure codes beginning with 402, 403, 533, 535 and 599 occur, and to take the pump out of service for inspection by authorized service personnel. The users were also advised to avoid getting fluid on the tubing set or in the pump channel to lessen the occurence of the 810:04 and 810:11 failure codes. If those code failures occur, the pump should be taken out of service for inspection by authorized service personnel. The users were informed that software upgrades are being developed to correct the inadvertent power off problem and to mitigate failure code 16:336 occurrences. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867.


  • Model / Serial
    all serial numbers
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide distribution: USA, Puerto Rico, United Kingdom, Canada, Brazil, Hong Kong, Taiwan, Turkey, Kuwait, South Africa, Chile, Saudi Arabia, Korea, Mexico, Colombia, New Zealand, the Bahamas, Belgium, El Salvador, Guatemala, Honduras, Israel, Lebanon, Panama, the Philippines and the United Arab Emirates.
  • 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, 2M8151R, BRM8151(Brazilian Portugese), DNM8151(French), HNM8151(German), PNM8151(Spanish), CNM8151(Swedish), GNM8151(Danish), TRM8151(Turkish), WNM8151(Dutch) , 2M8161, 2M8161R
  • Manufacturer


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