Image English Cuando compra jabones y geles de baño, ¿busca usted los productos que dicen “antibacteriano” en la etiqueta con la esperanza de que mantendrán más segura a su familia? ¿Cree que estos productos reducirán su riesgo de enfermarse, propagar gérmenes o infectarse? Según la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA,…
Surgical Mask and Gown Conservation Strategies – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits (scrubs), may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak. The following conservation strategies for use by health care organizations and…
Fresenius Kabi’s Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)
Summary Company Announcement Date: April 23, 2020 FDA Publish Date: April 27, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description presence of particulate matter Company Name: QuVa Pharma, Inc. Brand Name: Brand Name(s) Product Description: Product Description R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe Company Announcement SUGAR…
Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets
Image Español 简体中文 You have probably seen and heard a lot about the coronavirus (COVID-19) and how to keep you and your family safe. But what about the other, furrier members of the family—your pets? Below, the U.S. Food and Drug Administration offers some questions and answers to help keep you, your family, and…
Barbecue Basics: Tips to Prevent Foodborne Illness
[embedded content] Español It’s the season for picnics, cookouts, and other outdoor parties. But eating outdoors in warm weather presents a food safety challenge. Bacteria in food multiply faster at temperatures between 40°F and 140°F, so summer heat makes the basics of food safety especially important. “Fortunately, there are a lot of steps consumers can…
Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use
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…
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…