Recall Overview

  On April 3, 2010 the U.S. Food and Drug Administration ordered Baxter International to recall and destroy over 200,000 of its Colleague brand volumetric infusion pumps. According to the FDA this action is based on a longstanding failure to correct many serious problems associated with the pumps since a 2005 recall. The Colleague brand pumps have received approximately 56,000 complaints and reports of injuries, several deaths and malfunctions from 2005 to 2009. Additionally, the FDA has ordered Baxter to provide refunds to it's customers and/or replace the pumps at no cost. Since 1999 the FDA has been working in conjunction with Baxter to correct numerous device problems. The Colleague pumps have been the subject of several FDA Class I recalls for issues like battery swelling, inadvertent power off, interface errors and software defects which could lead to electric shocks or failure to properly deliver the correct amount of fluids or medicine. In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until Baxter corrected manufacturing deficiencies and until devices in use were brought into compliance. Since the 2006 consent decree Baxter has made numerous changes to the Colleague pumps but these changes have not corrected the product defect. If you, or someone you love, have been injured using a Baxter Colleague Volumetric Infusion Pumpand would like the attorneys at Nolan Law Group to review your potential case, please contact us.

What is a Infusion Pump

The Baxter Colleague Volumetric Infusion Pump is a medical device that delivers intravenous fluids and medicine to patients in hospitals, outpatient surgical centers, hospices, nursing homes, and in ambulances. It is used throughout the hospital, including in the emergency room, the I.C.U., labor and delivery, and in pediatric units.

Recall Timeline

The Colleague pump has been subject to several corrective action notices and recalls since the middle of 2005. February 25, 2005: Baxter issues an "Important Product Information" letter regarding it's Colleague Volumetric Infusion Pumps due to reports of the devices shutting down while delivering medication and fluids to patients. Accroding to reports Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected are: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R. March 15, 2005: a "Urgent Device Corrective" notice is issued to Baxter's customers expanding its list of known issues with the Colleague Volumetric Infusion Pumps. Issues in the March 2005 "Urgent Device Correction" included: - Inadvertent Power off - External communication port failures - Pump Failure Codes July 20, 2005: The first "Urgent Product Recall" was reported due to circuit design issue where the product was displaying failure codes and stopping in the middle of infusions. At the time of the July 20, 2005 recall, there were reports of three deaths and six serious injuries associated with the issues identified in the March 15, 2005 Urgent Device Correction notice. November 15, 2005: Baxter International Inc. informed the FDA it was withdrawing the 6060 Multi-Therapy Infusion pump because of problems happening when the device is used to distribute pain and other critical medications. Dec 13, 2005: Baxter issued another "Urgent Device Correction" to it's customers This letter focused on issue with Battery Undercharging, Generation of False Air Detected Alarm due to IV Administration Set Tugging, Gearbox Wear, Underinfusion and Non-Detection of Upstream Occlusion. Patient injuries and deaths were associate with some of these issues in the letter Aug 7, 2007:A second "Urgent Product recall"  was issued in Aug of 2007. The letter expanded the recall to include over 1500 devices. It discussed irregularities in service and repair documentation (apparently three employees in an Arizona service facility falsified repair, test and inspection data sheets). January 23, 2009: Urgent Device Correction Letter issued by Baxter on January 23, 2009. This letter discussed issues with Colleague Single and Triple Channel Volumetric Infusion Pumps. These pumps were manufactured and distributed from February, 1997 through December, 2008. In their recall letter Baxter identified software and battery usage failures which result in a delay in or interruption of infusion that have already caused serious injury and/or death. The models effected were Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163 March of 2009: The U.S. Food and Drug Administration (FDA) classified Baxter's January 23, 2009 Urgent Device Correction letter to customers regarding U.S. COLLEAGUE(R) Volumetric Infusion Pumps as a Class I recall. There have been seven Class I recalls of Colleague infusion pumps by the FDA since 2005. A Class I recall is the FDA's most serious type (only issued when a device poses a risk of serious injury or patient death if it malfunctions). If you, or someone you love, have been injured using a Baxter Colleague Volumetric and would like the attorneys at Nolan Law Group to review your case, please contact us.

Legal Rights

If you or someone you love have been injured from the use of a recalled Baxter Colleague Volumetric Infusion Pump you have the right to file a legal claim. Our attoneys can help you determine if you have a case and how to file a claim. All claims are handled on a contingency fee basis, meaning you do not have to pay attorney fees unless you are awarded compensation. If you would like the attorneys at Nolan Law Group to review your case, please contact us.