FDA Warns Teleflex Over Device Quality Failures

Law360, New York (August 16, 2006, 12:00 AM EDT) -- The Food and Drug Administration has sent a warning letter to Teleflex Incorporated saying the company’s medical device unit has not been adequately investigating its products or reporting product complaints to regulators as required.

During an inspection of the business in North Carolina conducted between March 21 and May 11, investigators found that the company was violating the methods it uses to pack, store or install its Kirschner Wires, Steinmann Pins and Hem-o-lok Endoscopic Ligating Clip Appliers.

Kirschner wires and Steinmann Pins are used to stabilize...
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