Events

Recall of Device Recall Colleague CX 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
    Recall
  • Event ID
    60521
  • Event Risk Class
    Class 2
  • Event Number
    Z-0598-2012
  • Event Initiated Date
    2009-05-08
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105786
  • 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
    infusion pump - Product Code FRN
  • Reason
    There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.
  • Action
    Baxter sent a service technician to the consignee location on 05/08/2009 to perform the battery check and discharge test. The pump was found to be within specification.

Device

Device Recall Colleague CX Infusion Pump
  • Model / Serial
    Product Code: 2M8161, Serial Number 12050019CC
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Puerto Rico
  • Product Description
    Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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