FDA Rips Covidien Response To Surgery Device Safety Issues

Law360, New York (June 26, 2012, 5:15 PM EDT) -- 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...
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