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In January, Covidien recalled its surgical staples device following reports of 13 injuries and three deaths. That same month, the FDA investigated a Covidien plant in Connecticut and documented several violations that were not specified in the original Boston Business Journal report. Covidien reportedly received its first complaint about the DUET device in 2009.
In its letter to Covidien, the FDA warned that the company failed to document any investigative actions or corrective plans regarding the defective device. Failure to initiate corrective action steps could lead to regulatory action, including civil penalties, the FDA warned.
A Covidien spokesman said the company is working to meet the FDA’s demands regarding both the DUET device and deficiencies at its Connecticut facility.
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