Murilo Freitas – Page 4 – PRAIS 2.0

Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes – Letter to Health Care Providers

Murilo Freitas - 04:00, 25 de March de 202580

Read the FDA’s recommendations related to four recalls of Megadyne Mega 2000 and Mega Soft patient return electrodes for patient burn injuries.

http://www.fda.gov/medical-devices/letters-health-care-providers/safe-use-megadyne-mega-2000-and-mega-soft-patient-return-electrodes-letter-health-care-providers

Endotracheal Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation

Murilo Freitas - 04:00, 24 de March de 202571

ORAL/NASAL Endotracheal Tubes keep air flowing through a patient’s airway, but some tubes may be smaller in diameter than expected.

http://www.fda.gov/medical-devices/medical-device-recalls/endotracheal-tube-recall-smiths-medical-removes-intubation-oralnasal-endotracheal-tubes-due-smaller

FDA Roundup: March 21, 2025

Murilo Freitas - 19:44, 20 de March de 2025115

FDA Roundup: March 21, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-21-2025

HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods

Murilo Freitas - 18:06, 19 de March de 202599

HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods
http://www.fda.gov/news-events/press-announcements/hhs-fda-announce-chemical-contaminants-transparency-tool-foods

Update on Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular

Murilo Freitas - 04:00, 19 de March de 2025100

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

http://www.fda.gov/medical-devices/medical-device-recalls/update-alert-atherectomy-catheter-system-issue-bard-peripheral-vascular

Early Alert: Aspiration System Issue from Calyxo

Murilo Freitas - 04:00, 19 de March de 202573

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

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-aspiration-system-issue-calyxo

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Update on Alert: Infusion Pump Issue from Baxter Healthcare Corporation

Murilo Freitas - 04:00, 19 de March de 2025101

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

http://www.fda.gov/medical-devices/medical-device-recalls/update-alert-infusion-pump-issue-baxter-healthcare-corporation

Infusion Pump Software Correction: Becton, Dickinson and Company (BD) Issues Correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Due to Risk for Outdated Automated Programming Requests to Load

Murilo Freitas - 04:00, 19 de March de 202587

Software from Alaris System Manager and CCE Infusion Adapter needs updates so outdated infusion information does not load to the Alaris infusion pump system.

http://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-software-correction-becton-dickinson-and-company-bd-issues-correction-bd-alaris

Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause Separation

Murilo Freitas - 04:00, 18 de March de 2025136

A manufacturing error may cause ProPort Plastic Implantable Ports, which are used in patients who need repeat venous access for treatment, to separate before, during, or after implantation.

http://www.fda.gov/medical-devices/medical-device-recalls/implantable-port-recall-smiths-medical-removes-proport-plastic-implantable-ports-due-manufacturing

FDA Roundup: March 18, 2025

Murilo Freitas - 19:06, 17 de March de 202592

FDA Roundup: March 18, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-18-2025

PRAIS 2.0