Date Recall |
December 13, 2005 See also: |
Product: |
All models of Baxter Healthcare Corp. COLLEAGUE®
Volumetric Infusion Pumps. |
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 |
Reason for Recall: |
Battery Undercharging: The pump’s
battery charge level indicator may overstate the battery power level and
shut down when operating on battery power if not charged for a full 12
hours following a “low battery” alarm. Any of these failures may delay or interrupt therapy, which could result in a life-threatening situation for patients, depending on the type of therapy being administered. |
Public Contact: |
Center for One Baxter |
FDA District: |
Chicago |
FDA Comments: |
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 800-422-9837, or visit Baxter’s website. |
Updated February 2, 2006
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