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Class I Medical Device Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps - Recall, Refund and Replace

Posted Nov 30 2010 12:00am

Recall Class: Class I

Date Recall Initiated: August 4, 2010

Product(s):
All Colleague Single Channel Infusion Pumps
All Colleague Triple Channel Infusion Pumps

Use: Colleague Single and Triple Channel infusion pumps are medical devices that deliver intravenous fluids and medicine to patients in hospitals, outpatient surgical centers, hospices, nursing homes, and in ambulances. They are used throughout the hospital, including in the emergency room, the I.C.U., labor and delivery, and in pediatric units.

Recalling Firm: Baxter Healthcare Corporation

Reason for Recall: On May 3, 2010, the FDA ordered Baxter Healthcare Corporation to recall and destroy all Colleague infusion pumps in the US market. FDA determined that this action was necessary, since Baxter failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague pumps still in use. This recall is a consolidation of all previous open Colleague recalls.

Public Contact:

Customers needing additional information may contact their local Baxter sales representative or call Center for One Baxter at 1-800-422-9837 during the hours of 8:00 AM – 5:00 PM Central Standard Time.

FDA District: Chicago

FDA Comments:

On August 4, 2010, Baxter Healthcare Corporation sent an “ Urgent Product Recalldisclaimer icon letter to all Colleague infusion pump customers in the United States. The letter provides information regarding action customers must take in order to continue receiving support and service for their Colleague infusion pumps during the recall. This includes:

  1. Completing a Certificate of Medical Necessity and returning it to Baxter no later than November 14, 2010.
  2. Identifying alternative products for replacing the Colleague Pumps
  3. Implementing those alternative pumps by July 14, 2012.

Baxter has provided Colleague customers with a Transition Guide describing the steps customers must take to transition to an alternative FDA cleared or approved infusion pump and to be eligible for replacement or refund from Baxter. The Transition Guide as well as other information and resources related to the recall, refund, and replacement of Colleague pumps is available on the Baxter Colleague Transition Information Center web site .


This recall encompasses all previous recalls of the Colleague infusion pump. Customers may continue to use Colleague pumps in accordance with the operator’s manual and the additional instructions contained in previous Colleague Recall and Field Corrective Action communication. All open Colleague Recall and Field Corrective Actions communications are available on Baxter’s website at: http://www.baxter.com/information/safety_information/colleague.html .


FDA has developed strategies for health care providers and hospital administrators to reduce the risks associated with infusion pumps. These strategies are available on FDA’s Infusion Pump Initiative ( www.fda.gov/infusionpumps ) web site.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program by:

Useful Links:

    
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