Baxter Healthcare and the FDA have announced the Class 1 Recall of Baxter COLLEAGUE and FLO-GARD Volumetric Infusion Pumps.
The recall includes 534 infusion pump devices in the United States that were brought into the company’s service center for maintenance and repair. The company found falsified repair, test, and inspection data sheets, including electrical safety data. The products are being recalled because these devices may not have been repaired or serviced which could pose a danger to the consumer.
Baxter has dismissed three employees associated with the falsified information and all affected customers have been notified. So far there have been no reports of injury or death from consumers.
The FDA has classified this action as a Class 1 recall because if the device malfunctions, patients could sustain serious injuries or even death.
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.
The recalled models include:
FLO-GARD Volumetric Infusion pump: 2M8063 2M8064
COLLEAGUE Volumetric Infusion pump: 2M8151 2M8153
COLLEAGUE CX Volumetric Infusion pump: 2M8161 2M8163
For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.