The company is ready to resume shipments following 510(k) clearance from the Food and Drug Administration (FDA) for a software correction that will be implemented on new Alaris PC units.
“The 510(k) clearance for our software correction is another important milestone in our continued progress under the amended consent decree,” said Dwight Winstead, chief operating officer of CareFusion. “We will continue to work closely with the FDA to fulfill all of our obligations under the amended consent decree and execute within our new quality system to manufacture products that are among the safest in the industry.”
The 510(k) clearance follows FDA acceptance of the company’s corrective action plan for field remediation of its infusion pumps that was announced on June 9. For Alaris PC units already with customers, CareFusion will begin implementing the software correction as part of this corrective action plan.
