Starion gets warning letter over reporting of device malfunctions

08/24/2010 | MassDevice.com (Boston)

Starion Instruments received a warning letter from the FDA stating that it failed to properly report problems with its TLS3 thermal ligating shears and TLS4 RealHand thermal seal system and handle complaints correctly. The agency said the company's initial response regarding the problems was inadequate.

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MassDevice.com (Boston)

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