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FDA Roundup: December 8, 2023

Murilo Freitas - 19:10, 7 de diciembre de 202329

FDA Roundup: December 8, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-8-2023

FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

Murilo Freitas - 16:10, 7 de diciembre de 202336

FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease
http://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease

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2023 Medical Device Recalls

Murilo Freitas - 05:00, 7 de diciembre de 2023708

2023 Medical Device Recalls

http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls

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Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive

Murilo Freitas - 05:00, 7 de diciembre de 202332

Getinge is recalling the CARDIOHELP Emergency Drive because it can become stuck or difficult to turn due to friction being generated in the handle attachment.

http://www.fda.gov/medical-devices/medical-device-recalls/getinge-recalls-cardiohelp-emergency-drive-due-impaired-or-inability-turn-drive

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Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays

Murilo Freitas - 05:00, 6 de diciembre de 202326

In direct response to the Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urolo

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-issues-medical-device-recall-nurse-assist-products-contained-within-kitstrays

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Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication

Murilo Freitas - 05:00, 6 de diciembre de 202348

Reports of smoke, sparks, fire, and burns stemming from use of the DreamStation2 CPAP machines prompt warning from the FDA.

http://www.fda.gov/medical-devices/safety-communications/carefully-monitor-philips-dreamstation-2-cpap-machines-signs-overheating-fda-safety-communication

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FDA Roundup: December 5, 2023

Murilo Freitas - 21:59, 4 de diciembre de 202338

FDA Roundup: December 5, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-5-2023

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Cordis US Corp Recalls INFINITI Angiographic Catheter due to Products Being Shipped Without Undergoing Sterilization Procedures

Murilo Freitas - 05:00, 4 de diciembre de 202336

The Cordis INFINITI Angiographic Catheter is being recalled due to some of the products being shipped to end users without undergoing sterilization procedures.

http://www.fda.gov/medical-devices/medical-device-recalls/cordis-us-corp-recalls-infiniti-angiographic-catheter-due-products-being-shipped-without-undergoing

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FDA, USDA and EPA Propose National Strategy to Reduce U.S. Food Loss and Waste

Murilo Freitas - 14:04, 3 de diciembre de 202342

FDA, USDA and EPA Propose National Strategy to Reduce U.S. Food Loss and Waste
http://www.fda.gov/news-events/press-announcements/fda-usda-and-epa-propose-national-strategy-reduce-us-food-loss-and-waste

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Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication

Murilo Freitas - 05:00, 3 de diciembre de 202360

A voluntary recall initiated by SoClean for use of SoClean2 and SoClean3 equipment to clean, sanitize or disinfect CPAP devices and accessories.

http://www.fda.gov/medical-devices/safety-communications/voluntary-recall-soclean-equipment-intended-use-cpap-devices-and-accessories-fda-safety