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US FDA Nod For Baxter's Colleague Infusion
Pump
Baxter Healthcare Corporation has received clearance from the
US FDA on its Colleague infusion pump 510(k) pre-market notification. The
company is preparing to modify pumps currently in the market and will soon
submit manufacturing and service documentation to FDA in advance of deploying
upgrades to US Colleague infusion pumps. Baxter will continue to communicate and
work directly with customers in the coming months to establish deployment
schedules and begin remediation activities.
"Resolving issues with the Colleague infusion pump has been
Baxter's top priority. We appreciate customers' continued support as we've
worked to develop modifications for the Colleague infusion pump," said, Peter
Arduini, corporate vice president and president of Baxter's Medication Delivery
business. "Baxter remains committed to our infusion systems customers and will
continue to invest in this business to enhance the delivery of life-saving
medications."
Baxter has completed deployment activities in key markets
outside the US, with 58,000 pumps in 55 countries upgraded, and then resumed
sales of Colleague infusion pumps in these markets.
In June 2006, Baxter and FDA reached agreement in the form of
a consent decree, which describes steps Baxter must take to resume sales of new
Colleague infusion pumps in the US. Currently, more than 200,000 Colleague
infusion pumps are in use in US hospitals.
(Ref : Chronicle Pharmabiz dated March 8, 2007)
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