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(Reuters) - The U.S. Food and Drug Administration (FDA) on Friday said it had identified the recall of B. Braun Medical Inc's medicine-delivering pump system as most serious.
The U.S. Food and Drug Administration issued a Class I recall, the agency's most serious, for the Medfusion syringe pump, the third major FDA recall for the line of devices made in Oakdale. Smiths ...
The recall by the U.S. Food and Drug Administration of one medical company's entire line of infusion pumps -- widely used to administer fluids to the human body -- has called attention to ...
An infusion pump infuses fluids, ... and problems with such pumps have been linked to more than 56,000 adverse event reports from 2005 to 2009, ... (FDA) has launched ...
A New England Compounding Center meningitis outbreak that began in September 2012 sickened 798 individuals and resulted in the deaths of more than 100 people. [2] [3] [4] In September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal ...
Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines ...
The labeling updates, which FDA classified as its most serious Class I recall, gave revised instructions for using the device, such as carefully positioning the pump catheter during operative ...
Pump and infusion set (catheter) placement Insulin basal bolus profile. Insulin pumps are drug delivery devices used to treat patients with type 1 and type 2 diabetes. The Minimed Paradigm REAL-Time and Continuous Glucose Monitoring (CGM) system, which received FDA clearance in 2006, uses tubing and a reservoir with rapid-acting insulin.
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