Blog – Page 5 – PRAIS 2.0

Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue

Murilo Freitas - 05:00, 27 de November de 2025111

Dropping or severely jarring Alaris Pumps may damage critical pump components. Do not use dropped or jarred devices until thoroughly inspected and tested

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-becton-dickinson-updates-use-instructions-bd-alaris-pump-issue

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Recall Alert: Baxter Permanently Removes Life2000 Ventilation System

Murilo Freitas - 05:00, 25 de November de 202572

Baxter is permanently removing all Life2000 Ventilation Systems after discovering a cybersecurity issue that may allow unauthorized access to the device

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-baxter-permanently-removes-life2000-ventilation-system

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Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform

Murilo Freitas - 05:00, 25 de November de 202571

Balt USA is removing their Mega Ballast because of the unintended presence of loose hydrophilic coating inside the tube at the tip end

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-balt-usa-removes-mega-ballast-distal-access-platform

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PAHO: Avian influenza A(H5N1) continues circulation in the Americas

admin - 00:18, 25 de November de 202553

PAHO: Avian influenza A(H5N1) continues circulation in the Americas

Cristina Mitchell

25 Nov 2025

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Brasil assina acordo com a OPAS para aquisição de vacinas atualizadas por meio dos Fundos Rotatórios

admin - 10:00, 24 de November de 202567

Brazil signs agreement with PAHO to update vaccines through the Revolving Funds

Luis Felipe Cunha

25 Nov 2025

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Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices

Murilo Freitas - 05:00, 24 de November de 202557

SpeedControl Dials used with SmartDrive MX2+ Power Assist Devices may be unresponsive to users and fail to stop or start unexpectedly, causing injury

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-max-mobilitypermobil-removes-all-speedcontrol-dials-used-smartdrive-mx2-power-assist

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FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy

Murilo Freitas - 22:24, 23 de November de 202558

FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy
http://www.fda.gov/news-events/press-announcements/fda-approves-gene-therapy-treatment-spinal-muscular-atrophy

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Early Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue from Fresenius Kabi

Murilo Freitas - 05:00, 23 de November de 202568

Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-large-volume-pump-primary-administration-set-reverse-flow-issue-fresenius-kabi

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