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.…
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…
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…
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…
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…
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…
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…
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…
FDA recommends healthcare workers transition away from decontaminated N95 masks
Editor's Note The Food and Drug Administration (FDA), on April 9, sent a letter to healthcare providers recommending they “transition away from crisis capacity conservation strategies,” including disinfection and reuse of N95 masks. Though the FDA believes there is an adequate supply of N95s now to facilitate this transition, the…
Public perspectives on who should be prioritized for COVID-19 vaccine
Editor's Note In this study from the University of Denver and the University of Pennsylvania, Philadelphia, respondents to two surveys agreed with the National Academies of Science, Engineering, and Medicine’s prioritization framework for COVID-19 vaccination. Of 4,735 respondents (2,730 to a Gallup survey and 2,005 to a COVID Collaborative survey):…
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