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Blog Posts in January, 2015

  • FDA STRENGTHENS MARKETING REQUIREMENTS FOR DEFIBRILLATORS AFTER NUMEROUS DEVICE FAILURES

    The FDA recently issued a final order requiring "more rigorous review" of automated external defibrillators (AEDs) in order to improve the safety and reliability of such medical devices on the market. AEDs are portable devices used to "provid[e] a rapid response to victims of cardiac arrest" by "automatically analyz[ing] the heart rhythm... and deliver[ing] an electrical shock to the heart to ...
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  • FDA ISSUES RECALL NOTICE ABOUT KIMVENT* MICROCUFF* ENDOTRACHEAL TUBES

    The FDA recently warned healthcare professionals of a recall of Halyard Health's KimVent* Microcuff* Endotracheal Tubes. These devices are plastic tubes "inserted into the windpipe (trachea)... to open an airway for mechanical breathing [or]... to remove fluid that builds up in the windpipe during a procedure." Halyard Health has recalled endotracheal tubes distributed between December 2013 and ...
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