FDA Announces Baxter Flo-Guard Pump Repairs Not Performed, Inspections Falsified

Courtney Mills

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On August 13, 2007 the FDA announced in a preliminary Public Health Notification that Baxter Healthcare Corporation failed to perform certain diagnostic tests, repair, or service on its Infusion FLO-GARD pumps sent to the company for servicing. The company further revealed that falsified repair documents had been issued for the repairs, including falsified inspection data sheets and electrical safety data for COLLEAGUE and FLO-GARD infusion pumps serviced at Baxter's Phoenix, Arizona plant.

The company is in the process of investigating the matter, but has urged all hospitals and customers to contact Baxter for repeat inspection. The company initially recalled the pump devices and expanded the recall August 3 from 534 to 986 units.

The specific units singled out in the FDA notification are COLLEAGUE Single Channel Volumetric Infusion Pumps, Product Codes 2M8151 and 2M8161; the COLLEAGUE Triple Channel Volumetric Infusion Pumps, Product Codes 2M8153 and 2M8163; the FLO-GARD 620l Volumetric Infusion Pump, Product Code 2M8063; and the FLO-GARD 6301 Volumetric Infusion Pump, Product Code 2M8064.