The Deerfield-based Baxter Healthcare company has reached an agreement with the Food and Drug Administration over its allegedly faulty intravenous pumps.
Baxter’s pumps are used in hospitals to administer medicines to patients intravenously.
The company provides about 200,000 pumps in the U.S. and 50,000 abroad.
But the FDA raised concerns of a faulty design and a possible safety issue.
Yesterday’s settlement will give the company 20 days to come up with a plan to fix the design flaws.
Baxter spokeswoman Erin Gardiner says the company changed the design but there’s no need to recall the pumps.
“Pumps currently in use in hospitals are safe to use if used in accordance with the operator’s manual and instructions previously communicated to customers.”
The Colleague and Syndeo pumps cost about $2,500 dollars each.
The company has not sold the pumps since last June and won’t resume sales until the FDA approves a design change.