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Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab
Monday, April 19, 2021Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.... Read More -
CareFusion 303, Inc. Recalls BD Alaris Pump Module Model 8100 Due to Risk of Stuck or Unresponsive Keys
Friday, April 16, 2021CareFusion 303 Inc is recalling the Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry. This could lead to keys that become unresponsive or stuck (See Figure 1). This may lead to an infusion delay or interruption or prevent clinicians from changing fluid or... Read More -
Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports
Friday, April 16, 2021Medtronic is recalling the HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports because of risk of wear and tear of the connector plugs (power sources, data cable, and alarm adapter) which could cause damage to the Controller port metal pins (for example, bent pins). Read More -
Janssen COVID-19 Vaccine Frequently Asked Questions
Thursday, April 15, 2021On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows Janssen COVID-19 Vaccine to... Read More -
Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine
Wednesday, April 14, 2021As of April 12, 2021, approximately 6.85 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine (Janssen) have been administered in the United States. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are reviewing data involving six... Read More -
Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum
Tuesday, April 13, 2021Smisson-Cartledge Biomedical is recalling their ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets because a part of the ThermaCor 1200 Disposable Set, the cassette (See Figure 1), which warms fluids directly with an aluminum plate may leak aluminum into the fluids and expose patients to... Read More -
Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery Life
Monday, April 12, 2021Medtronic is recalling the specified ICDs and CRT-Ds due to an unexpected and rapid decrease in battery life. The decrease in battery life is caused by a short circuit and will cause some devices to produce a “Recommended Replacement Time” (first warning that the battery is low) earlier... Read More -
FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities
Friday, April 9, 2021The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. Based on the increased domestic supply of new respirators... Read More -
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System
Wednesday, April 7, 2021The U.S. Food and Drug Administration today announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples. Samples collected at home are then sent... Read More -
A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits Due to Mislabeling
Monday, April 5, 2021Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is being... Read More
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