U.S. Food and Drug Administration - CDRH Mobile
Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule

FDA > CDRH > Medical Device Recalls > Class I Recall - Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps

Medical Device Recalls
Class I Recall - Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps

Date Recall
Initiated:

September 19, 2005

Product:
 All models of Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps.
Affected Models are: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.
Use:
 These electronic infusion pumps are used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream.
Recalling Firm:
 Baxter Healthcare Corporation
Rt. 120 & Wilson Road
Round Lake, IL 60073
Reason for Recall:
 The pump’s batteries have been known to experience battery swelling and/or excessive discharge failures. Both of these failures will result in irreversible damage to the battery. If either one of these failures occurs, the pump would be incapable of operating on battery power for the expected amount of time, thus leading to interruption or prevention of therapy and the possible death and/or serious injury of patients. Additionally, it should be noted that when the batteries become damaged due to excessive discharge, the battery charge level indicator will overstate the amount of battery charge remaining.
Public Contact:
 Center for One Baxter
Baxter Healthcare Corporation
1 Deerfield Parkway
Deerfield, IL 60015
800-422-9837
FDA District:
 Chicago
FDA Comments:
  • This recall does not require the return of infusion pumps currently in the market.
  • Baxter has advised health care institutions to have a backup pump available to mitigate any disruptions of infusions of life-sustaining drugs or fluids.
  • In an Important Product Information Letter dated February 25, 2005, Baxter notified its users of the actions they can take to minimize the occurrence of these device failures, including following proper battery maintenance procedures. Baxter's letter to customers is available on its Web site at http://www.baxter.com/about_baxter/news_room/downloads/ColleagueFeb05.pdf.
  • On July 21, 2005 Baxter announced that the company would voluntarily hold shipments of new pumps until issues are resolved. Baxter continues to address this issue as part of its remediation efforts.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

 

Consumers with questions may contact the company at 1-(847) 843-7867.
Baxter's letters to customers and press releases are available on its web site at www.Baxter.com.

The FDA press release announcing the Baxter COLLEAGUE® Volumetric Infusion Pumps recall is available at http://www.fda.gov/bbs/topics/NEWS/2005/NEW01209.html.

Updated September 28, 2005

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH