Baxter Infusion Pumps Recalled Because of Service Error

Posted on April 29, 2008

Baxter Healthcare Corporation has recalled certain COLLEAGUE and FLO-GARD infusion pumps that were sent back to the company for service. These pumps may have been returned to users without the service being performed on them.

The recall initially involved over 500 COLLEAGUE and FLO-GARD pumps, but it has been expanded to include approximately 2000 more pumps with certain model and serial numbers (see links below under "Additional Information").

Check the serial numbers on FLO-GARD and COLLEAGUE pumps. If a pump is affected by this recall, the pump should be taken out of service and returned to Baxter for a repeat inspection and servicing. The company says it will provide free loaner units while pumps are being serviced. Baxter Healthcare Corporation can be reached at 1-800-THE-PUMP.

If a facility has sent back the units affected by this particular recall but is still using other COLLEAGUE pumps that did not get the upgrade, Baxter’s previous safety notices and FDA's Preliminary Public Health Notification should be reviewed for information about earlier Baxter infusion pump recalls.

Note that beginning in May 2007, some COLLEAGUE pumps got an upgrade that was cleared by FDA. These pumps are not part of this recall. The upgraded units can be identified by two plastic hang-tags that say "Power On" and "Battery." If a pump has those tags, it has been upgraded. The upgraded pumps also have a test-screen for the speaker that comes up when the power is turned on.

Additional Information:

FDA MedWatch Safety Alert. Baxter Healthcare Corporation COLLEAGUE and FLO-GARD Volumetric Infusion Pumps. September 25, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#pumps

Serial Numbers for Baxter Colleague CX Infusion Pumps, product codes 2M8161. September 19, 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=55495

Serial Numbers for Baxter Colleague CX Infusion Pumps, product codes 2M8151 and 2M8161. July 28, 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=53189

Serial Numbers for Baxter Colleague CX Infusion Pumps, product codes 2M8153 and 2M8163. July 28, 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=53190

Serial Numbers for Baxter Flo-Gard Infusion Pumps, product code 2M8063. June 28, 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=53174

Serial Numbers for Baxter Flo-Gard Infusion Pumps, product code 2M8064. June 28, 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=53176

Baxter Corporation Website. COLLEAGUE Volumetric Infusion Pump Press Releases. August 21, 2007.
http://www.baxter.com/products/medication_management/infusion_pumps/large_volume_infusion_pumps/colleague/colleague_status.html