Blog – Page 28 – PRAIS 2.0

Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device Disassembly

Murilo Freitas - 04:00, 21 de July de 2025142

Medline Craniotomy Kits are procedure convenience kits. Kits containing the Codman Disposable Perforator are being corrected by Medline Industries.

http://www.fda.gov/medical-devices/medical-device-recalls/medical-procedure-kits-correction-medline-industries-lp-issues-correction-medline-craniotomy-kits

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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 2025179

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

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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 2025279

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

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

Murilo Freitas - 04:00, 20 de July de 2025219

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

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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 2025293

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

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Paraguay establece Mesa Consultiva para fortalecer la atención primaria de salud con apoyo de la OPS, Banco Mundial y el BID

admin - 14:00, 16 de July de 2025334

Paraguay establishes advisory council to strengthen primary health care with support from PAHO, World Bank, and IDB

Cristina Mitchell

17 Jul 2025

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

Murilo Freitas - 04:00, 16 de July de 2025268

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

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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 2025235

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

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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 2025226

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

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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 2025451

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