Medtronic announced today that a previously communicated global voluntary recall to address an issue with certain lots of its Trellis-6 and Trellis-8 peripheral infusion systems has now been classified as a Class 1 Recall by the U.S. Food and Drug Administration. Customers were previously notified by Covidien of the recall on December 15, 2014.
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Press Release for Hanbit Enterprises, Inc. dba Jack and the Beanstalk Recalls Soybean Sprouts Because of Possible Health Risk
Hanbit Enterprises, Inc. dba Jack and the Beanstalk is recalling Soybean Sprouts in 1lb, 1.5lb, 10 lb, and Natto plastic bags distributed up to and including February 12, 2015 with Best if Used by dates up to February 19, 2015, 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 long-‐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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Moscahlades Bros Inc. Recalls Hellas Golden Double Smoked Herring Because of Possible Health Risk
Moscahlades Bros Inc. of Paterson, NJ is recalling Hellas Golden Double Smoked Herring because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
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FDA issues new draft documents related to compounding of human drugs
Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.
FDA approves Lenvima for a type of thyroid cancer
The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).
Natural Grocers by Vitamin Cottage Issues Recall on Organic Garlic Powder Due to Possible Health Risk
Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling two lots of Natural Grocers brand Organic Garlic Powder as the product has the potential to be contaminated with Salmonella. Consumption of products containing Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
California food company to cease operations for repeated food safety violations
A San Francisco, California-based food company, Fong Kee Tofu Co., Inc., and its owners, Jen Ying Fong, Suny Fong, and Yan Hui Fan, have agreed not to process or distribute food until it has been demonstrated to the U.S. Food and Drug Administration that its facility and practices comply with federal food safety requirements.
FDA permits marketing of fecal incontinence device for women
The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women.
New data shows test can help physicians remove patients with suspected TB from isolation earlier
The FDA today cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be kept in a hospital airborne isolation room.
Kent, WA Firm Issues Allergy Alert on Undeclared Soy and Egg Allergens in Small Heart Strawberry Tray with Devonshire Dip
Real Foods in Kent, WA is initiating a voluntary recall of 356 cases (712 units) of Small Heart Strawberry Tray with Devonshire Dip, due to misbranding and undeclared allergens. The company was alerted to the issue by a retail operation selling the product, that the strawberry trays were incorrectly packaged with Buttermilk Ranch Dressing in place of Devonshire Dip.
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