FDA Bars Michigan Firm From Selling Heart Machines

By: Associated Press
By: Associated Press

WASHINGTON (AP) -- The federal government is legally barring a Michigan company from selling medical devices used in heart surgery, following years of quality control problems at company facilities.
The Food and Drug Administration says it signed a permanent injunction with Terumo Cardiovascular Systems and two executives that bars them from making or distributing heart-lung bypass systems. The devices are used to circulate blood during chest surgery.
Terumo agreed to pay $35 million in back profits from the sale of its devices.
Last March, FDA inspectors reported more than a dozen quality control violations at the company's plant in Ann Arbor. The company was cited for similar problems in 2004 and 2006.
The FDA said it is not recalling Terumo's products from the market because of concerns about a shortage of the machines.


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