Baxter International Inc. has expanded their recall on its Colleague and Flo-Gard infusion pumps to include 986 more devices. The previous recall , which was announced on July 25, included 534 pumps that were recalled due to falsified service records.
The company discovered that some of the devices sent to the Baxter service center may have been sent back to consumers without being serviced. Baxter found falsified repair, test, and inspection data sheets, which included electrical safety data. The employees responsible for the falsified data were fired. The company has decided to expand the recall because the company wants to ensure the safety of their customers.
The recall has been classified as a Class 1 recall because if the infusion pump malfunctions, patients could incur a 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.
Affected model numbers include: FLO-GARD Model Numbers 6201 and 6301 Volumetric Infusion pump, Product Codes: 2M8063 and 2M8064; COLLEAGUE Volumetric Infusion pump, Product Codes: 2M8151 and 2M8153; and COLLEAGUE CX Volumetric Infusion pump, Product Codes: 2M8161 and 2M8163.
For more information on this subject, please refer to our section on Defective and Dangerous Products.