9
Feb
Posted in Uncategorized by Food and Drug Administration--Recalls/Safety Alerts |
Acacia, Inc. (formally known as MPS Acacia) has voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. The BD Q-Syte™ Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson and Company).
9
Feb
Posted in Uncategorized by Food and Drug Administration--Press Releases |
On Feb. 8 the U.S. Food and Drug Administration approved the cholesterol-lowering medication Crestor (rosuvastatin) for some patients who are at increased risk of heart disease but have not been diagnosed with it.
The new indication is for reducing the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients who have never been told they have heart disease but are nevertheless at increased risk of a cardiac event.
9
Feb
Posted in Uncategorized by Food and Drug Administration--Recalls/Safety Alerts |
Cardiac Science Corporation [NASDAQ: CSCX] is initiating a worldwide voluntary recall after determining that approximately 12,200 automated external defibrillators (AEDs) may not be able to deliver therapy during a resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. The FDA has been informed of this situation.
9
Feb
Posted in Uncategorized by Food and Drug Administration--Recalls/Safety Alerts |
Turkey Hill Dairy of Conestoga, Pa., is recalling its 1.5 qt. (48 oz./1.42L) packages of Chocolate Marshmallow Premium Ice Cream because the product may contain almonds that were inadvertently added during production.
9
Feb
Posted in Uncategorized by Food and Drug Administration--Recalls/Safety Alerts |
BD (Becton, Dickinson and Company) (NYSE:BDX) has voluntarily executed a product recall of certain lots ofBD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems. Use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
9
Feb
Posted in Uncategorized by Food and Drug Administration--Press Releases |
The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.
5
Feb
Posted in Uncategorized by Food and Drug Administration--Press Releases |
The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.
5
Feb
Posted in Uncategorized by Food and Drug Administration--Press Releases |
The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.
5
Feb
Posted in Uncategorized by Food and Drug Administration--Recalls/Safety Alerts |
Cousins Products, LLC, of Covington, LA is voluntarily recalling the following Spinach Vinaigrette in 16 oz. jars
5
Feb
Posted in Uncategorized by Food and Drug Administration--Recalls/Safety Alerts |
Cousins Products, LLC, of Covington, LA is voluntarily recalling the following Spinach Vinaigrette in 16 oz. jars