FDA Rips Covidien Response To Surgery Device Safety Issues

Law360, New York (June 26, 2012, 5:15 PM ET) -- Covidien PLC didn't adequately respond to safety issues surrounding its tissue reinforcement system Duet TRS — which it voluntarily recalled in January after three patients died — and didn't comply with federal manufacturing requirements, according to a U.S. Food and Drug Administration warning letter released Tuesday.

The agency said an inspection of Covidien's facility in North Haven, Conn., between Jan. 13 and Feb. 6 revealed the company's Duet TRS devices were adulterated in a way that didn't conform with current, good manufacturing practice requirements outlined in...
To view the full article, register now.

DEWEY LIVE BLOG

Follow our exclusive coverage of the trial of the year:

Dewey Trial Day 49