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…
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…
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…
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…
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…
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…
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…
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…
FDA authorizes Pfizer-BioNTech COVID-19 vaccine boosters for certain populations
Editor's Note The Food and Drug Administration (FDA) on September 22 amended the emergency use authorization (EUA) for Pfizer-BioNTech’s COVID-19 vaccine to allow for use of a single booster to be administered at least 6 months after completion of the primary series in those: 65 years of age and older…
FDA: Class I recall of Medtronic Pipeline Flex Embolization devices
Editor's Note The Food and Drug Administration (FDA), on September 20, identified Medtronic’s recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology as Class I, the most serious. The devices, which are used to treat brain aneurysms, were recalled because there is a risk…
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