FDA – MedWatch – Baxter Healthcare Corp. Recalls Baxter COLLEAGUE And FLO-GARD Volumetric Infusion Pumps Because Of Falsification Of Service And Repair Data
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
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 1-800-422-4770.
