Boston Scientific (NYSE: BSX) has initiated a global, voluntary recall of all models of its Fetch™ 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage.
Category Archives: Food & Drug Recalls
Vascular Solutions, Inc. Issues Recall of Guardian® II Hemostasis Valves
Vascular Solutions, Inc. (Nasdaq: VASC), initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. Specific lots of the products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death.
FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
The U.S. Food and Drug Administration today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with a least one prior therapy. Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL.
Progressive Gourment Inc. Issues an Allergy Alert on Taste of Inspirations Edamame Rangoon Due to Possible Mislabeling and Undeclared Crustacean Shellfish
Progressive Gourmet Inc. of Wilmington, MA, is voluntarily recalling its frozen, 9 ounce packages of Taste of Inspirations Edamame Rangoon out of an abundance of caution because they have the potential to contain crustacean shellfish (crab). People who have an allergy to crustacean shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.
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FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns
Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a carcinogenic residue.
Michel Et Augustin Inc. Issues Allergy Alert on Undeclared Hazelnuts in Petites Baguettes Butter Cookies Dark Chocolate
Michel et Augustin Inc. of Brooklyn, NY, is recalling approximately 900 packages of its Petites baguettes butter cookies Dark Chocolate, 6 packs only, because they may contain undeclared hazelnuts. People who have an allergy to hazelnuts run the risk of serious or life-threatening allergic reaction if they consume this product.
WD Import and Export Inc. Issues an Alert on Dried Fish Due To Possible Health Risk
WD Import and Export Inc. located at 4703 2nd Ave, Brooklyn, NY 11232 is recalling its bulk unlabeled cardboard boxes of Dried Yellow Fish 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 allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients
The U.S. Food and Drug Administration today permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.
Granna’s LLC Issues Allergy Alert On Undeclared Milk in French Toast
Granna’s LLC is voluntarily recalling packages of item number 808 French Toast that may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA approves first leadless pacemaker to treat heart rhythm disorders
The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.