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The Food and Drug Administration (FDA) is warning hospital risk managers, surgical service managers and infection control professionals that a device used in surgical and endoscopy suites for sterilizing or disinfecting medical devices has been modified, has not been approved by the FDA, and may not properly disinfect or sterilize instruments, which may pose a serious risk to patients and health care staff.
The Food and Drug Administration (FDA) is investigating certain types of medical devices made by Hospira Inc. and Abbott Nutrition after 122 reports of sparking, charring and fires from the power cords used with the devices. The announcement follows a recall announcement and FDA warning last August on some medical devices made by Hospira Inc. because of faulty electrical cords that could lead to serious injury or death.
A group of FDA scientists recently sent a six-page letter to Barack Obama’s transition team venting consternation over their agency’s corruption and mismanagement. It’s not the first time FDA scientists have sought the help of Washington, pleading for a shakeup, but the number of complaints and the overall tone of the latest letter indicate agency insiders are eager to grab some of the new President’s much promised change.
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