Supply Chain/Technology

Latest Issue of OR Manager
February 2022
Home Supply Chain/Technology

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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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: 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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Effect of indoor air changes on COVID-19 transmission

Editor's Note In this JAMA Insights article, researchers from the Harvard School of Public Health, Boston, and University of Michigan, Ann Arbor, conclude that increasing air changes per hour and air filtration are simple concepts that could be used to help reduce within-room, far-field (ie, within-room but beyond 6 feet)…

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By: Judy Mathias
April 20, 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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Studies assess use of Mako System in joint arthroplasty

Editor’s Note. This article presents value-based analyses on the use of Mako robotic technology in total knee, partial knee, and total hip arthroplasty. The authors are with Stryker Orthopaedics in Mahwah, New Jersey.   Joint arthroplasty is an effective procedure to treat advanced osteoarthritis of the hips and knees. It…

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By: Kevin Barga, MS, RN and Andrea Coppolecchia, MPH
April 19, 2021
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FDA: Class I recall of Medtronic’s Valiant Navion Thoracic Stent Graft System

Editor's Note The Food & Drug Administration (FDA), on April 9, identified the recall of Medtronic’s Valiant Navion Thoracic Stent Graft System as Class I, the most serious. The recall was initiated because of the risk of stent fractures and endoleak concerns. The system is used to repair lesions of…

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By: Judy Mathias
April 12, 2021
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HHS report finds US hospitals in crisis

Editor's report A new report released by the Department of Health and Human Services (HHS) Office of Inspector General (OIG) on March 23 details how the COVID-19 pandemic has created new problems and worsened existing issues at US hospitals, leaving staff frustrated, exhausted, and burned out. Among the problems outlined…

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By: Judy Mathias
March 25, 2021
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FDA: Class I recall of Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface

Editor's Note The Food and Drug Administration (FDA), on March 24, identified the recall by Medtronic of its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface as Class I, the most serious. The recall was issued because of potentially elevated levels of harmful bacterial endotoxins. Use of a device…

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By: Judy Mathias
March 25, 2021
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FDA: Class I recall of ACIST Kodama Intravascular Ultrasound Catheter

Editor's Note The Food and Drug Administration (FDA), on March 17, identified the recall by ACIST of its Kodama Intravascular Ultrasound Catheter as Class I, the most serious. The recall was initiated because the O-ring housing tubing may squeeze and damage the O-ring. If there is damage, broken O-ring pieces…

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By: Judy Mathias
March 23, 2021
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Latest Issue of OR Manager
February 2022
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