Murilo Freitas – PRAIS 2.0

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

Murilo Freitas - 20:16, 26 de June de 202542

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies
http://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor

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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

Murilo Freitas - 20:00, 26 de June de 202549

Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-nationwide-recall-one-lot-cefazolin-injection-due-product-mispackaging

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Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation

Murilo Freitas - 04:00, 24 de June de 202542

Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact.

http://www.fda.gov/medical-devices/medical-device-recalls/angiographic-catheter-recall-cook-removes-beacon-tip-angiographic-catheters-due-tip-separation

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mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

Murilo Freitas - 04:00, 24 de June de 202554

mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

http://www.fda.gov/safety/medical-product-safety-information/mrna-covid-19-vaccines-fda-safety-communication-fda-approves-required-updated-warning-labeling

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Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula

Murilo Freitas - 04:00, 23 de June de 2025141

The Shiley Adult Flexible Tracheostomy Tube is being recalled as it may come loose if the flange disconnects, potentially leading to a blocked airway.

http://www.fda.gov/medical-devices/medical-device-recalls/flexible-tracheostomy-tube-recall-medtronic-removes-shiley-adult-flexible-tracheostomy-tube

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Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers

Murilo Freitas - 04:00, 23 de June de 2025119

The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries.

http://www.fda.gov/medical-devices/letters-health-care-providers/import-alerts-certain-olympus-medical-devices-manufactured-japan-letter-health-care-providers

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Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic

Murilo Freitas - 04:00, 23 de June de 202551

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-esophageal-ph-monitoring-capsule-issue-medtronic

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Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication – FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch

Murilo Freitas - 04:00, 22 de June de 202569

The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and o

http://www.fda.gov/safety/medical-product-safety-information/transderm-scop-scopolamine-transdermal-system-drug-safety-communication-fda-adds-warning-about

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