The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Vascular Solutions, Inc. Langston Dual Lumen Catheter Lot Numbers: Lots distributed between July 12, 2019 and March 10, 2020 Model Number: Model 6F 5540 Manufacturing Dates: June…
CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets
Summary Company Announcement Date: April 27, 2020 FDA Publish Date: April 29, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids Company Name: CME America Brand Name: Brand Name(s) CMEAmerica BodyGuard Product Description:…
Tips on Good Nutrition and Using the Updated Nutrition Facts Label During the Coronavirus Pandemic
Image The coronavirus (COVID-19) pandemic has shifted many of our daily routines, including the ways we eat. Perhaps you have stocked up on packaged foods and find yourself cooking at home more than usual. As we adjust, you may want to think about ways you and your family can eat more healthfully. “The Nutrition Facts…
Court Orders Halt to Sale of Silver Product fraudulently Touted as COVID-19 Cure
Department of Justice FOR IMMEDIATE RELEASEWednesday, April 29, 2020 A federal court in Utah has entered an injunction halting the sale of a fraudulent coronavirus (COVID-19) treatment, the Department of Justice announced today. In response to a civil complaint and accompanying court papers filed on April 27, 2020, in Salt Lake City, the U.S. District Court for…
GSK Consumer Healthcare Recalls Benefiber Healthy Shape Prebiotic Fiber Supplement and Benefiber Prebiotic Fiber Supplement Due to Possible Plastic Contamination from the Bottle Cap
Summary Company Announcement Date: April 28, 2020 FDA Publish Date: April 28, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential for plastic pieces or shavings Company Name: GSK Consumer Healthcare Brand Name: Brand Name(s) Product Description: Product Description Prebiotic Fiber Supplement Company Announcement GSK Consumer Healthcare is voluntarily recalling five…
Condies Foods Issues Allergy Alert on Undeclared Soy Allergen in Chicken Salad on Croissant Single Item# 43237 and Chicken Sandwich on White Single Item# 43559
Summary Company Announcement Date: April 29, 2020 FDA Publish Date: April 29, 2020 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared soy Company Name: Condies Foods Brand Name: Brand Name(s) Condies Foods Product Description: Product Description Chicken salad sandwiches Company Announcement Condies Foods of Kearns, UT is recalling 165 units…
The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons
February 9, 2017 Dear Health Care Provider, The FDA has recently received multiple reports for two different types of adverse events associated with liquid-filled intragastric balloons used to treat obesity. We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications…
UPDATE: Potential Risks with Liquid-filled Intragastric Balloons – Letter to Health Care Providers
April 27, 2020 – UPDATE: Potential Risks with Liquid-filled Intragastric Balloons – Letter to Health Care Providers December 9, 2019 LHCP UPDATE: As of January 1, 2019, Apollo Endosurgery stopped selling and distributing the ReShape Balloon (which was acquired by Apollo Endosurgery in December 2018). Because the ReShape Balloon is no longer available, the post-approval study…
Court Prohibits Dallas Wellness Center from Touting ‘Ozone Therapy’ as COVID-19 Treatment
Department of JusticeU.S. Attorney’s OfficeNorthern District of Texas FOR IMMEDIATE RELEASEFriday, April 24, 2020 A federal court entered a permanent injunction halting a purported “ozone therapy” center in Dallas from offering unproven treatments for COVID-19, U.S. Attorney Erin Nealy Cox announced today. In a civil case filed in U.S. District Court for the Northern District of Texas,…
Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication – FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems
[Posted 04/24/2020] AUDIENCE: Consumer, Patient, Critical Care Medicine, Infectious Disease, Health Professional ISSUE: FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease. We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or…