Murilo Freitas – PRAIS 2.0

Stanford faculty member George Tidmarsh, M.D., Ph.D. named Director of Center for Drug Evaluation and Research

Murilo Freitas - 10:57, 20 de July de 202518

Stanford faculty member George Tidmarsh, M.D., Ph.D. named Director of Center for Drug Evaluation and Research
http://www.fda.gov/news-events/press-announcements/stanford-faculty-member-george-tidmarsh-md-phd-named-director-center-drug-evaluation-and-research

rss

Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use Instructions for Servo Ventilator Systems Due to Risk of Inaccurate Compliance Measurement Leading to Improper Tidal Volume Delivery in Neonatal Patients

Murilo Freitas - 04:00, 20 de July de 202514

Maquet is updating Servo Ventilator instructions due to a risk of inaccurate tidal volume delivery when the extended leak test is used.

http://www.fda.gov/medical-devices/medical-device-recalls/continuous-ventilator-respirator-correction-maquet-critical-care-ab-updates-use-instructions-servo

rss

Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential Sterility Concerns

Murilo Freitas - 04:00, 20 de July de 202520

MicroMyst Applicators are being recalled due to potential non-sterile product., but these devices may not have been properly sterilized.

http://www.fda.gov/medical-devices/medical-device-recalls/applicator-recall-integra-lifesciences-removes-micromyst-applicators-due-potential-sterility

rss

FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths

Murilo Freitas - 22:49, 17 de July de 202557

FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths
http://www.fda.gov/news-events/press-announcements/fda-requests-sarepta-therapeutics-suspend-distribution-elevidys-and-places-clinical-trials-hold

rss

Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter

Murilo Freitas - 04:00, 17 de July de 202544

Manual resuscitator recalled due to incorrect B/V filter assembly that could delay therapy. May cause hypoxia, hypercapnia, or death if used.

http://www.fda.gov/medical-devices/medical-device-recalls/manual-resuscitator-recall-sunmed-holdings-llc-removes-adult-manual-resuscitator-devices-due

rss

Early Alert: Microbore Extension Set Issue from B. Braun Medical Inc.

Murilo Freitas - 04:00, 16 de July de 202549

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-microbore-extension-set-issue-b-braun-medical-inc

rss

Portable Oxygen Concentrator Car Adapter Recall: Drive DeVilbiss Healthcare Removes iGo DV6X-619 DC Car Adapter Due to Cord Possibly Becoming Hot to the Touch and/or Melting While Being Used

Murilo Freitas - 04:00, 16 de July de 202543

Drive Devilbiss Healthcare is recalling iGo2 DV6X-619 DC car adapter due to complaints of the DC power cord being hot to the touch and/or melting while used.

http://www.fda.gov/medical-devices/medical-device-recalls/portable-oxygen-concentrator-car-adapter-recall-drive-devilbiss-healthcare-removes-igo-dv6x-619-dc

rss

BD Issues Update to Voluntary Global Recall of Alaris™ and BD Alaris™ Pump Modules Serviced with Legacy Bezel Kit Assemblies

Murilo Freitas - 04:00, 16 de July de 202545

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued a voluntary recall related to certain Alaris™ and BD Alaris™ Pump Modules that may have been serviced with previously recalled bezel kit assemblies.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-issues-update-voluntary-global-recall-alaristm-and-bd-alaristm-pump-modules-serviced-legacy-bezel

rss

Continuous Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom G6, G7, ONE, and ONE+ Receivers Due to Speaker Malfunction That May Cause Missed Alerts for Dangerous Blood Sugar Levels

Murilo Freitas - 04:00, 16 de July de 202555

Dexcom recalls certain receivers that may fail to sound alerts. Missed alerts could delay detection of severe blood sugar events, causing seizures or death.

http://www.fda.gov/medical-devices/medical-device-recalls/continuous-glucose-monitor-receiver-recall-dexcom-inc-removes-certain-dexcom-g6-g7-one-and-one

rss

FDA to Revoke 52 Obsolete Standards of Identity for Food Products

Murilo Freitas - 15:23, 15 de July de 202542

FDA to Revoke 52 Obsolete Standards of Identity for Food Products
http://www.fda.gov/news-events/press-announcements/fda-revoke-52-obsolete-standards-identity-food-products