Tag: FDA

FDA: Class I recall of Aligned Medical Solutions custom convenience kits

Editor's Note The Food and Drug Administration (FDA), on November 9, identified the recall by Aligned Medical Solutions of its custom convenience kits as Class I, the most serious. The recall was initiated because of the potential for the plunger in Cardinal Health's Monoject Flush Prefilled Syringe (0.9% sodium chloride),…

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By: Judy Mathias
November 11, 2021
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FDA investigating imported surgical, exam gloves

Editor's Note The Food and Drug Administration (FDA), on September 29, announced that healthcare facilities and providers should not purchase or use imported surgical and patient examination gloves from companies included on Import Alert 80-04. Companies are listed on an import alert when the FDA has enough evidence that they…

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By: Judy Mathias
November 3, 2021
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FDA: Class I recall of Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs

Editor's Note The Food and Drug Administration (FDA), on October 29, identified the recall by Datascope/Getinge/Maquet of its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs as Class I, the most serious. The recall was initiated because of the risk of the battery failing and having a shortened run time, which…

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By: Judy Mathias
November 1, 2021
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FDA: Class I recall of DeRoyal procedure packs containing Smiths Medical Normoflo irrigation warming sets

Editor's Note The Food and Drug Administration (FDA), on October 6, identified the recall by Deroyal Industries of its procedure packs containing Smiths Medical Normoflo irrigation warming sets as Class I, the most serious. The recall was initiated because of the possibility of harmful levels of aluminum leaching into the…

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By: Judy Mathias
October 28, 2021
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ECRI issues statement on COVID-19 vaccine boosters, global vaccine equity

Editor's Note In an October 26 news release, ECRI announced the publication of a Position Statement on “COVID-19 Vaccines: Mitigating Disease and Promoting Global Health Equity.” Speaking in support of the Statement, Marcus Schabacker, MD, PhD, president and chief executive officer, ECRI, says: “Despite the FDA and CDC’s advancement of…

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By: Judy Mathias
October 27, 2021
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CDC expands eligibility for COVID-19 boosters

Editor's Note The Centers for Disease Control and Prevention (CDC) director Rochelle P. Walensky, MD, MPH, on October 21, endorsed the CDC Advisory Committee on Immunization Practices’ recommendation for a booster of COVID-19 vaccines in certain populations. For individuals who received Pfizer-BioNTech or Moderna COVID-19 vaccines, the following are eligible…

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By: Judy Mathias
October 26, 2021
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FDA: Class I recall of Imperative Care ZOOM 71 Reperfusion Catheter

Editor's Note The Food and Drug Administration (FDA) on October 6 identified the recall by Imperative Care Inc of its ZOOM 71 Reperfusion Catheter as Class I, the most serious. The ZOOM 71 Reperfusion Catheter is used to remove blood clots from a patient’s brain within 8 hours of an…

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By: Judy Mathias
October 12, 2021
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FDA: Class I recall of Amsorb Plus used to absorb carbon dioxide in anesthesia machines

Editor's Note The Food and Drug Administration (FDA), on September 23, identified the recall by Armstrong Medical of certain lots of its Amsorb Plus Prefilled G-Can 1.0L canisters as Class I, the most serious. Amsorb Plus is a chemical substance used in anesthesia machines to absorb carbon dioxide the patient…

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By: Judy Mathias
October 5, 2021
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ECRI partners with FDA on safety of materials in medical devices

Editor's Note ECRI, on September 30, announced a new partnership with the Food and Drug Administration (FDA) to improve the safety of medical devices through the use of safer materials. ECRI is developing safety reports for materials commonly used in implantable medical devices and assessing their possible effects on patients…

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By: Judy Mathias
October 1, 2021
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Outdoor daylight exposure, longer sleep promote wellbeing during COVID-19 restrictions

Editor's Note This study by Israeli researchers finds that restrictions implemented during COVID-19 dramatically altered daily routines and limited time spent outdoors, which resulted in deteriorating personal wellbeing. The analysis of 7,517 adults from 40 countries who were surveyed during the 2020 COVID-19 restrictions found that social restrictions impaired all…

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By: Judy Mathias
September 23, 2021
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