Baxter’s voluntary recall action regarding falsification of service and repair data for the COLLEAGUE and FLO-GARD infusion pumps

Source | Baxter Healthcare Corp.

Models Include: COLLEAGUE Volumetric Infusion pump 2M8151 and 2M8153; COLLEAGUE CX Volumetric Infusion pump 2M8161 and 2M8163;  FLO-GARD Volumetric Infusion pump 2M8063 and 2M8064

DEERFIELD, Ill., July 25, 2007 – Baxter Healthcare Corporation today announced that the U.S. Food and Drug Administration (FDA) has classified Baxter’s voluntary recall action regarding falsification of service and repair data for the COLLEAGUE and FLO-GARD infusion pumps as a Class I recall. The recall pertained to 534 infusion pump devices in the U.S. brought in for routine maintenance or corrections at the company’s Phoenix, Arizona service center.

“In the course of its ongoing quality control processes, the company discovered falsified repair, test and inspection data sheets, which included electrical safety data.”

Therefore, it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. Three employees in the Phoenix service center associated with this matter have been dismissed. The company has recalled affected devices and has informed all customers to contact Baxter and return the pumps for repeat inspection. All affected customers have been notified and no serious injuries or patient deaths have been associated with this action to date. This recall action impacts only pumps distributed in the United States.

This action has been classified by FDA as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction. A defect may result in over-infusion, 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. Affected model numbers include: FLO-GARD Volumetric Infusion pump 2M8063 and 2M8064; COLLEAGUE Volumetric Infusion pump 2M8151 and 2M8153; and COLLEAGUE CX Volumetric Infusion pump 2M8161 and 2M8163.