The FDA wants CareFusion to stop selling its anesthesia breathing circuit and the Denver ascites shunt and percutaneous access kit until it applies for clearance for changes made to the devices and clears up some quality control issues at a plant in Illinois.
CareFusion (NYSE:CFN) drew another warning letter from the FDA last month after an inspection last year revealed unapproved device changes and quality control process problems at a plant in Vernon Hills, Ill.
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