Murilo Freitas – Page 17

Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss

Murilo Freitas - 18:20, 23 de April de 2025201

Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss

http://www.fda.gov/medical-devices/medical-device-recalls/heart-pump-accessory-removal-abbott-removes-heartmate-mobile-power-unit-due-instances-sudden-power

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Risk of False Positive Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication

Murilo Freitas - 16:00, 23 de April de 2025162

FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

http://www.fda.gov/medical-devices/safety-communications/risk-false-positive-results-certain-capillary-blood-collection-tubes-used-magellan-diagnostics

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HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply

Murilo Freitas - 20:12, 21 de April de 2025227

HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply
http://www.fda.gov/news-events/press-announcements/hhs-fda-phase-out-petroleum-based-synthetic-dyes-nations-food-supply

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Early Alert: Intravascular PICC Catheter Issue from BD

Murilo Freitas - 16:52, 17 de April de 2025176

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-intravascular-picc-catheter-issue-bd

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Early Alert: Diagnostic Intravascular Catheter Issue from Conavi

Murilo Freitas - 14:25, 17 de April de 2025245

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-diagnostic-intravascular-catheter-issue-conavi

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FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I

Murilo Freitas - 04:00, 17 de April de 2025203

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072

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FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees

Murilo Freitas - 18:59, 16 de April de 2025263

FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees
http://www.fda.gov/news-events/press-announcements/fda-commissioner-makary-announces-new-policy-individuals-serving-fda-advisory-committees

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FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus

Murilo Freitas - 21:01, 10 de April de 2025255

FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus
http://www.fda.gov/news-events/press-announcements/fda-honored-welcome-hhs-secretary-robert-f-kennedy-jr-fda-campus

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FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs

Murilo Freitas - 19:33, 9 de April de 2025304

FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
http://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs

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Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

Murilo Freitas - 04:00, 6 de April de 2025186

Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns. The recall was originally initiated on December 20, 2024, and has been expanded to address recalled product that may hav

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-expands-nationwide-recall-smartdrive-speed-control-dial-due-motor-being