In March 2014, Datascope Corp/MAQUET initiated a voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT (Part Numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx), CS100/CS100i (Part Numbers: 0998-00-3013-xx, 0998-UC-3013-xx, 0998-UC-0446Hxx and 0998-UC-0479Hxx) and CS300 (Part Numbers: 0998-00-3023-xx, 0998-UC-3023-xx) IABP brand names for a potential mechanical failure of the fan assembly associated with the power supply.
FDA allows marketing of first prosthetic arm that translates signals from person’s muscles to perform complex tasks
The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.
FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients
The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
STE Fromagere Du Livradois Voluntarily Recalls Raclette Cheese and Montboissie Cheese for Possible Health Risk
Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses lot#350 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
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MDA Issues Consumer Advisory for Five Flavors of Lily Bloom’s Kitchen Poparoons Milk Ingredient was Undeclared on Labels
The Minnesota Department of Agriculture (MDA) is notifying consumers that Lily Bloom’s Kitchen of Fridley, Minnesota, has issued an allergy alert for undeclared allergens in five flavors of Poparoons, a macaroon-type confection. The label did not declare milk as an ingredient.
Alere Initiates Voluntary URGENT PRODUCT RECALL of Alere INRatio 2 PT/INR Professional Test Strips
WALTHAM, Mass. – Alere Inc. (NYSE:ALR) has initiated a voluntary Class 1 recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2). This action is a result of complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Eugene Oregon, Inc. Issues Voluntary Nationwide Recall of African Black Ant, Black Ant, and Mojo Risen Dietary Supplements Which May Contain Undeclared Active Pharmaceutical Ingredients
Eugene Oregon, Inc. is voluntarily conducting this recall because FDA analysis of these products distributed to a third party revealed that the distributed products contained undeclared amounts of the active pharmaceutical ingredients sildenafil and tadalafil—FDA-approved pharmaceutical ingredients used to treat erectile dysfunction. Conclusive testing has not been done to confirm that the recalled products do, in fact, contain sildenafil and/or tadalafil and this recall is being executed as a precautionary measure.
Pacific Organic Produce Announce Voluntary Recall of Mangos Due to Possible Health Risk
Pacific Organic Produce, San Francisco, CA is voluntarily recalling a limited number of cases of organic Tommy Atkins mangos (PLU numbers 94051 & 94959) that were sold under the Purity Organic brand between the dates of April 14, 2014
and May 2, 2014 due to a possible health risk from Listeria monocytogenes.
Sixdog Investments Voluntarily Recalls Eggs Because of Possible Health Risk
Sixdog Investments, LLC is voluntarily recalling some cases of their certified organic eggs, because of the potential they are contaminated with Salmonella. This voluntary field action was initiated because of routine testing results, and not because of illness to date from consumption.
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Blue Bunny Premium Bordeaux Cherry Chocolate Ice Cream Recalled for Undeclared Allergen
Wells Enterprises, Inc., maker of Blue Bunny ice cream said today it has recalled Blue Bunny Premium Bordeaux Cherry Chocolate Ice Cream sold at retail grocery stores in Kansas, Indiana and Iowa because the product may contain egg not declared on the label.