Scentsational Soaps & Candles, Inc. Issues Voluntary Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde

Angie Szumlinski Announcements, News

Company Announcement Scentsational Soaps & Candles, Inc., is voluntarily recalling 5 lots of Scentsational Soaps & Candles scented Hand Sanitizers from the Black and White Collection and Photo Real Collection and 3 lots of Ulta Beauty Collection scented Hand Sanitizer Spray packaged in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer level. See products listed in the …

Sleep Apnea – FDA Approval

Angie Szumlinski Featured, Studies

The U.S. Food and Drug Administration authorized marketing a new prescription-only device intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backward and obstructing the airway during sleep. …

Ventilator Splitters – Letter to Health Care Providers

Angie Szumlinski News

The U.S. Food and Drug Administration (FDA) is informing health care providers and health care facilities about up-to-date information concerning multiplexing ventilator tubing connectors, also know as ventilator splitters, in situations in which no alternatives for invasive ventilatory support are available. Although the FDA has not received any adverse event reports related to the use of ventilator splitters authorized for …

FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale

Angie Szumlinski Announcements, News

March 4, 2021 The U.S. Food and Drug Administration alerted consumers, health care providers, and other users of thermal imaging systems intended to measure human body temperature—also known as telethermographic systems, infrared thermographs, thermal cameras, and “fever cameras”—that improper use of the systems may provide inaccurate temperature readings due to a variety of factors. Additionally, the FDA issued several Warning …

FDA Letter of Authorization- Reissuance of Convalescent Plasma

Angie Szumlinski Health, Studies

On February 2, 2021, the U.S. Food and Drug Administration reissued an Emergency Use Authorization for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with Covid-19. This reissues the letter of authorization released on November 20, 2020, and also contained the following updates: Includes updates based on data from additional clinical trials. Clarifies that the …

FDA Import Alert on Alcohol-Based Hand Sanitizers

Angie Szumlinski Featured, Health

The US Food and Drug Administration has issued an import alert for alcohol-based hand sanitizers from Mexico. Largely due to the increase in the use of hand sanitizers in response to the Covid-19 pandemic, the FDA is issuing this warning to protect the safe supply of alcohol-based hand sanitizers and prevent products with dangerous ingredients from entering the country. In …

COVID-19 Vaccine Reactions – CDC MMWR

Angie Szumlinski Announcements, Health, News

The CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States and interim considerations for preparing for the potential management of anaphylaxis. Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination. In addition to screening for contraindications and precautions before administering COVID-19 vaccines, vaccine locations should have the …

FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation

Angie Szumlinski Health

On January 8, 2021, the U.S. Food and Drug Administration (FDA) issued an alert warning that viral mutations of SARS-CoV-2 may produce false-negative results on current molecular tests. “The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the …

Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19

Angie Szumlinski Health

The U.S. Food and Drug Administration (FDA) issued a statement describing the risks of false results with the Curative SARS-Cov-2 test, particularly false negative results. Risks to a patient who has received a false negative can include delayed care as well as lack of monitoring of infected individuals, which can result in increased community spread of the virus. Recommendations from …

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

Angie Szumlinski Announcements, Health

On January 4th, 2021, the U.S. Food and Drug Administration (FDA) released a statement reiterating the importance of following the authorized dosing schedules for both approved COVID-19 vaccines. Efforts to increase the number of individuals immunized against COVID-19 by changing the doses or dosing schedules are said to run the risk of being counterproductive to public health. The FDA is …