Baxter Healthcare Corp has received clearance from the FDA on its COLLEAGUE infusion pump 510(k) pre-market notification.
As Baxter makes preparations to upgrade its COLLEAGUE pumps in the US it will submit manufacturing and service documentation to the FDA in advance of deploying the modifications.
In June 2006, Baxter and the FDA reached an agreement in the form of a consent decree, which describes the steps Baxter must take to resume sales of new COLLEAGUE infusion pumps in the US. Baxter emphasizes that resolving issues with the pump has been the company’s top priority.
Currently, more than 200,000 COLLEAGUE infusion pumps are in use in US hospitals and Baxter says it will continue to communicate and work directly with customers in the coming months to establish deployment schedules and begin remediation activities.