On February 23 2012 Thoratec Corporation initiated a voluntary worldwide medical device correction notification of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalog No. 104692 103393 104911 or 104912
FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease
The Food and Drug Administration today approved the LINX Reflux Management System for people diagnosed with gastroesophageal reflux disease (GERD) who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.
FDA approves first Boniva generics to treat or prevent osteoporosis
The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.
El Ranchero Del Sur, LLC Recalls El Ranchero Queso Fresco (Fresh Cheese), Los Corrales Queso Fresco en Hoja de Platano (Fresh Cheese in Banana Leaf), and El Ranchero Queso Oaxaca (String Cheese) Because of Possible Health Risk
El Ranchero Del Sur, LLC. of South River, New Jersey is recalling El Ranchero Queso Fresco 14 oz. (Fresh Cheese), Los Corrales Queso Fresco en Hoja De Platano 14 oz. (Fresh Cheese In Banana Leaf), El Ranchero Queso Oaxaca 14 oz. and 10 lb. (String Cheese) because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Troyer Cheese, Inc. Recalls Backroad Country Caramel Puffcorn Sold in 8oz and 16oz Plastic Bags Because of Undeclared Milk
Troyer Cheese, Inc. is recalling specific expiration dates of their Backroad Country Caramel Puffcorn sold in 8 and 16 ounce plastic bags because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Recall of Brilliant Blue G Urgent Product Recall – Immediate Action Required
We have recently received reports that some patients treated with Brilliant Blue G have experienced fungal infections in the eye. The origin and cause of these eye infections has not yet been determined.
FDA proposes lower risk classification for certain tuberculosis tests
The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
FDA proposes lower risk classification, guidance for certain tuberculosis tests
The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis. This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
FDA approves first generic Lexapro to treat depression and anxiety disorder
The U.S. Food and Drug Administration today approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.
Depression is characterized by symptoms that interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person’s lifetime.
Publix Issues Allergy Alert On Publix Beef Stew Mix
McCormick & Company, Inc. has notified Publix Super
Markets of a voluntary recall for a single lot code of Publix Beef Stew Mix because it may be
mispacked with brown gravy and may contain undeclared milk. People who have an allergy
or severe sensitivity to milk run the risk of allergic reaction if they consume this product.