Tag: FDA

CDC relaxes mask guidelines for those fully vaccinated against COVID-19

Editor's Note The Centers for Disease Control and Prevention on May 13 announced that fully vaccinated individuals can discard masks and do away with social distancing outdoors and in most indoor settings. The agency still calls for wearing masks in crowded indoor settings, such as buses, planes, hospitals, prisons, and…

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By: Judy Mathias
May 17, 2021
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FDA: BD recalls certain lots of ChloraPrep

Editor's Note The Food & Drug Administration announced on April 20 that Becton, Dickinson and Company (BD) was recalling certain lots of its ChloraPrep Hi-Lite Orange 26 mL Applicator. ChloraPrep is used as an antiseptic to prepare a patient’s skin before surgery. The recall was initiated because the Applicator, which…

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By: Judy Mathias
May 11, 2021
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Hospira recalls one lot each of 0.5% Bupivacaine and 1% Lidocaine because of mislabeling

Editor's Note Hospira Inc, a Pfizer company, announced May 4 that it is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCL Injection, USP 30 mL because of mislabeling. A portion of each lot was incorrectly labeled as the other product.…

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By: Judy Mathias
May 6, 2021
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FDA: Class I recall of Alaris Infusion Pump Module 8100

Editor's Note The Food and Drug Administration, on April 30, identified the recall of the Alaris Infusion Pump Module 8100 as Class I, the most serious. The Pacific Medical Group (DBA Avante Health Solutions) is recalling the infusion pump because the front bezel components may crack or separate, leading to…

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By: Judy Mathias
May 3, 2021
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CDC: More than 98M Americans fully vaccinated against COVID-19

Editor's Note The Centers for Disease Control and Prevention (CDC), on April 28, reported that more than 98 million people in the US are fully vaccinated against COVID-19, which is 29.5% of the population. The count included two-dose vaccines from Moderna and Pfizer/BioNTech, as well as the Janssen/Johnson & Johnson’s…

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By: Judy Mathias
April 29, 2021
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CDC revises mask guidelines for fully vaccinated people

Editor's Note The Centers for Disease Control and Prevention (CDC), on April 27, announced new interim public health recommendations on activities fully vaccinated people can resume with and without wearing a mask. Among the recommendations: Fully vaccinated people can attend small gatherings outdoors with other vaccinated people or a mix…

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By: Judy Mathias
April 28, 2021
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FDA: Class I recall of Cordis Precise PRO Rx US Carotid System

Editor's Note The Food and Drug Administration (FDA), on April 26, identified the recall by Cordis Corporation of its Precise PRO Rx US Carotid System as Class I, the most serious. The Carotid System is being recalled due to a risk of separation of the atraumatic distal tip of the…

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By: Judy Mathias
April 27, 2021
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FDA, CDC lift pause on J&J COVID-19 vaccine

Editor's Note The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), on April 23, announced that after a thorough safety review, the pause on the Janssen/Johnson & Johnson (J&J) COVID-19 vaccine should be lifted, and use of the vaccine should resume. The pause was…

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By: Judy Mathias
April 26, 2021
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FDA: Class I recall of Medtronic’s Extracorporeal Blood Pumping Console

Editor's Note The Food and Drug Administration (FDA), on April 20, identified the recall of Medtronic’s Bio-Console 560 Extracorporeal Blood Pumping Console as Class I, the most serious. The Console is used during heart surgery to pump and return blood to a patient during cardiopulmonary bypass. The recall was initiated…

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By: Judy Mathias
April 22, 2021
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FDA issues Class I recall of certain Medtronic ICDs, CRT-Ds

Editor's Note The Food and Drug Administration (FDA), on April 12, identified the recall of Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of an unexpected and rapid…

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By: Judy Mathias
April 19, 2021
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