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U.S. Department of Health and Human Services

Safety

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Baxter Healthcare Corporation COLLEAGUE And FLO-GARD Volumetric Infusion Pumps

Audience: Hospital administrators, hospital risk managers, healthcare professionals, and consumers

[UPDATE 09/25/2007] Recall classified as Class I because there is a reasonable probability that use of the product will cause serious injury or death.

[UPDATE 08/14/2007] Baxter Healthcare and FDA notified healthcare professionals that certain Baxter COLLEAGUE and FLO-GARD Infusion Pumps sent to Baxter Healthcare Corporation for service, repair, or for correction may have been returned to users without service being performed on them. The company discovered falsified repair, test and inspection data sheets, including electrical safety data, for some of the referenced pumps serviced at its Phoenix, Arizona facility.

[UPDATE 08/08/2007] Baxter Healthcare and FDA notified healthcare providers and consumers that the July 25, 2007, Class I Recall of COLLEAGUE Infusion Pumps was expanded to include an additional 986 COLLEAGUE infusion pumps. The pumps should be returned to the company for repeat inspection because of falsified electrical safety data. See the Recall notice for the list of pumps affected by this recall.

[Posted 07/27/2007] Baxter Healthcare and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter COLLEAGUE and FLO-GARD Volumetric Infusion Pumps, Model numbers 2M8151 and 2M8153, COLLEAGUE CX Volumetric Infusion Pumps, Model numbers 2M8161 and 2M8163, and FLO-GARD Volumetric Infusion Pumps Model numbers 2M8063 and 2M8064.

The products were recalled because the firm identified repair, inspection, test data sheets, which included electrical safety data for the pumps, that were falsified. As a result it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. This may result in over/under infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line and malfunctions where the pump will stop infusing and result in an interruption of therapy that can lead to death. Return the affected pumps to Baxter Healthcare for repeat inspections and servicing. COLLEAGUE and FLO-GARD customers with questions should contact Baxter Healthcare Corp. at 1-800-422-9837.

[September 25, 2007 - Updated Recall Notice - FDA]
[August 14, 2007 - Preliminary Public Health Notification - FDA]
[August 07, 2007 - Updated Recall Notice - FDA]
[July 27, 2007 - Recall Notice - FDA]