- Associated Press - Tuesday, February 3, 2015

HUDSON, N.H. (AP) - The U.S. Department of Justice says a medical device maker in Hudson violated federal rules governing the way products are made, packaged, labeled or shipped.

Under an agreement announced Tuesday, Atrium Medical Corporation will have to pay $6 million and close temporarily - with some exceptions - until corrective measures are taken.

Atrium makes cardiovascular devices including chest drains, surgical meshes, vascular grafts and stents.

Inspections in 2013 found violations including failing to establish procedures for implementing corrective and preventive action. The company also failed to submit a report within 30 days of learning of information that suggested a device may have caused or contributed to a death or serious injury.

Those inspections followed similar findings in 2009, 2010 and 2012.

There was no answer at the company late Tuesday.

Copyright © 2018 The Washington Times, LLC.

The Washington Times Comment Policy

The Washington Times is switching its third-party commenting system from Disqus to Spot.IM. You will need to either create an account with Spot.im or if you wish to use your Disqus account look under the Conversation for the link "Have a Disqus Account?". Please read our Comment Policy before commenting.

 

Click to Read More and View Comments

Click to Hide