Murilo Freitas – Página 81

FDA Roundup: March 11, 2022

Murilo Freitas - 21:32, 10 de marzo de 2022344

FDA Roundup: March 11, 2022
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-11-2022

Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication

Murilo Freitas - 05:00, 10 de marzo de 2022399

The tests in a dark blue box have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.

http://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-acon-flowflex-covid-19-tests-fda-safety-communication

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Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events

Murilo Freitas - 05:00, 10 de marzo de 2022320

There is a risk of the pumps not delivering medication at the programmed rate displayed on the screen, and in some cases may not alarm for upstream occlusions.

http://www.fda.gov/medical-devices/medical-device-recalls/baxter-recalls-sigma-spectrum-infusion-pumps-master-drug-library-version-8-and-spectrum-iq-infusion

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ACON Laboratories Issues a Recall of Non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U.S. Market

Murilo Freitas - 05:00, 10 de marzo de 2022500

ACON Laboratories, Inc. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the U.S. distribution of unauthorized, adulterated and misbranded counterfeit product having the trade name “Flowflex SARS-C

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acon-laboratories-issues-recall-non-eua-authorized-flowflextm-sars-cov-2-antigen-rapid-test-self

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Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

Murilo Freitas - 05:00, 9 de marzo de 2022496

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.

http://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health

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Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification

Murilo Freitas - 05:00, 9 de marzo de 2022401

Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables to the consumer level. These compounded products were found to be out-of-specification.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympia-pharmacy-issues-voluntary-nationwide-recall-seven-compounded-products-due-being-out

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Firmado decreto que permite obtener permisos sanitarios de funcionamiento en un día

Murilo Freitas - 17:39, 8 de marzo de 2022380

Firmado decreto que permite obtener permisos sanitarios de funcionamiento en un día

09 de marzo 2022. Si antes un emprendedor debía esperar hasta siete días para obtener un permiso sanitario de funcionamiento de moderado o alto riesgo…

https://www.ministeriodesalud.go.cr/index.php/centro-de-prensa/noticias/749-noticias-2022/2286-firmado-decreto-que-permite-obtener-permisos-sanitarios-de-funcionamiento-en-un-dia

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Medtronic Recalls TurboHawk Plus Directional Atherectomy System Due to Risk of Tip Damage During Use

Murilo Freitas - 05:00, 8 de marzo de 2022391

This device is used during an atherectomy to treat patients who have calcified narrowings and blockages in the peripheral arteries.

http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-turbohawk-plus-directional-atherectomy-system-due-risk-tip-damage-during-use

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Marzo inicia con disminución de 21% en fallecimientos relacionados con COVID-19

Murilo Freitas - 19:02, 7 de marzo de 2022372

Marzo inicia con disminución de 21% en fallecimientos relacionados con COVID-19

Martes 8 de marzo, 2022. La semana epidemiológica 9 que abarcó del 27 de febrero al 5 de marzo se sumaron 84 decesos relacionados con COVID-19…

https://www.ministeriodesalud.go.cr/index.php/centro-de-prensa/noticias/749-noticias-2022/2285-marzo-inicia-con-disminucion-de-21-en-fallecimientos-relacionados-con-covid-19

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Tennessee Technical Coatings Corp Issues Nationwide Voluntary Recall of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% Due to Presence of Methanol

Murilo Freitas - 05:00, 6 de marzo de 2022383

Tennessee Technical Coatings Corp. is voluntarily recalling all lots of HAND SANITIZER Isopropyl Alcohol Antiseptic 75% to the consumer/user level. FDA analysis has found the product to contain methanol.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tennessee-technical-coatings-corp-issues-nationwide-voluntary-recall-hand-sanitizer-isopropyl