Fresh Express is announcing a precautionary recall of a limited number of cases of Organic Marketside Spring Mix.
Medtronic Announces Voluntary Worldwide Recall of its Stratamr Adjustable Valves and Shunts
Medtronic plc (NYSE: MDT) today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR adjustable valves and shunts. These products are manufactured and marketed by Medtronic’s Neurosurgery business, which is part of the Brain Therapies division of the company’s Restorative Therapies Group.
FDA approves two hepatitis C drugs for pediatric patients
The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults.
Isomeric Pharmacy Solutions Issues Voluntary Nationwide Recall of All Sterile Compounded Products
Isomeric Pharmacy Solutions (“Isomeric”) is voluntarily recalling all lots of sterile products compounded and packaged by Isomeric and that remain within expiry to the hospital/user level because of the US Food and Drug Administration’s concerns of a lack of sterility assurance. These concerns were brought to Isomeric’s attention during a recent inspection by the US Food and Drug Administration. To date, Isomeric has not received any reports of adverse events related to this recall.
FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions
The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.
Lakeside Foods, Inc. Recalls Season’s Choice Frozen Sweet Peas Because of Possible Health
Lakeside Foods, Inc. of Manitowoc, WI is voluntarily recalling 1,920 packages of 16 ounce Season’s Choice Brand Frozen Peas packed for Aldi, Inc. distributed in 7 states because it has 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.
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In Association with Lakeside Foods, Inc., ALDI Voluntarily Recalls Season’s Choice Frozen Sweet Peas
In cooperation with Lakeside Foods, Inc., and out of an abundance of caution, ALDI has voluntarily recalled Season’s Choice Frozen Sweet Peas due to possible Listeria monocytogenes contamination. Upon notification from the supplier, ALDI immediately removed the affected product from its stores.
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Medtronic Announces Worldwide Voluntary Field Corrective Action for Newport™ HT70 and Newport™ HT70 Plus Ventilators
Medtronic (NYSE: MDT) is notifying customers worldwide of a voluntary field corrective action for all its Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The voluntary field corrective action is being conducted following reports that the ventilator may reset spontaneously during normal operation, without an accompanying alarm. The reported incidence of this condition is approximately one (1) reset in every seven million hours of ventilation. Following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. In the event of the rare occurrence of a reset, healthcare professionals and/or caregivers are required to transfer the patient to another ventilator.
Medtronic Announces Worldwide Voluntary Field Corrective Action for Newport™ HT70 and Newport™ HT70 Plus Ventilators
Medtronic (NYSE: MDT) is notifying customers worldwide of a voluntary field corrective action for all its Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The voluntary field corrective action is being conducted following reports that the ventilator may reset spontaneously during normal operation, without an accompanying alarm. The reported incidence of this condition is approximately one (1) reset in every seven million hours of ventilation. Following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. In the event of the rare occurrence of a reset, healthcare professionals and/or caregivers are required to transfer the patient to another ventilator.
Olde York Issues Allergy Alert on Undeclared Milk in One Lot of Clancy’s Snack Combo 20 X 1 oz.
Olde York of Fort Wayne, IN is recalling the specific lot code SELL BY JUN 07 2017 2D9 for Clancy’s Snack Combo 20 x 1 oz (UPC 0 41498 12999 6) because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. No other lot codes and no other products are involved in this action.