FDAnews Device Daily Bulletin

Covidien Warning Letter Follows January Surgical Staple Recall

July 10, 2012
Covidien’s January recall of a surgical staple product hasn’t ended the company’s troubles, as an FDA warning letter questioning Covidien’s handling of safety concerns makes clear. The June 14 letter from the FDA’s New England District Office follows a Jan. 13-Feb. 9 inspection of Covidien’s New Haven, Conn., manufacturing plant.
The GMP Letter