Murilo Freitas – PRAIS 2.0

Early Alert: Convenience Kit Needle Issue from Integra LifeSciences

Murilo Freitas - 05:00, 22 de December de 202527

Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-convenience-kit-needle-issue-integra-lifesciences

Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft

Murilo Freitas - 05:00, 22 de December de 202516

Cook Medical is removing certain ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT proximal components because PTFE scrapings may enter the stent graft during deployment.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/endovascular-graft-recall-cook-medical-removes-zenith-alpha-2-thoracic-endovascular-graft

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MRI System Correction: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems

Murilo Freitas - 05:00, 22 de December de 202519

Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/mri-system-correction-siemens-healthineers-issues-correction-3-tesla-mri-systems

Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts

Murilo Freitas - 05:00, 22 de December de 202515

Drager is removing affected ErgoStar Cather Mounts due to cracks in the hose.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/catheter-mount-recall-draeger-removes-ergostar-catheter-mounts

Blood Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers

Murilo Freitas - 05:00, 21 de December de 202524

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/blood-pump-controller-correction-abiomed-updates-use-instructions-automated-impella-controllers

Cardiac Cannula Recall: Medtronic Removes DLP Left Heart Vent Catheter

Murilo Freitas - 05:00, 21 de December de 202522

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/cardiac-cannula-recall-medtronic-removes-dlp-left-heart-vent-catheter

Microbore Extension Set Recall: B. Braun Medical Inc. Removes Microbore Extension Sets

Murilo Freitas - 05:00, 21 de December de 202522

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/microbore-extension-set-recall-b-braun-medical-inc-removes-microbore-extension-sets

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Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pumps

Murilo Freitas - 05:00, 21 de December de 202526

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/infusion-pump-correction-baxter-issues-correction-novum-iq-large-volume-pumps

FDA Grants Two National Priority Vouchers

Murilo Freitas - 20:16, 18 de December de 202535

FDA Grants Two National Priority Vouchers
http://www.fda.gov/news-events/press-announcements/fda-grants-two-national-priority-vouchers

FDA Explores New Contracting Approach to Advance Public Health Innovation

Murilo Freitas - 15:02, 18 de December de 202532

FDA Explores New Contracting Approach to Advance Public Health Innovation
http://www.fda.gov/news-events/press-announcements/fda-explores-new-contracting-approach-advance-public-health-innovation

PRAIS 2.0