Murilo Freitas – Page 25

Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing Circuits due to Venturi Component Malfunctions that May Reduce Pressure and Volume Flow

Murilo Freitas - 05:00, 9 de February de 2025309

Phasitron Breathing Circuits support continuous ventilation. A malfunctioning venturi component in the circuit may cause reduced oxygen flow.

http://www.fda.gov/medical-devices/medical-device-recalls/breathing-circuit-kit-recall-sentecpercussionaire-removes-vdr4-phasitron-breathing-circuits-due

rss

Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach

Murilo Freitas - 05:00, 5 de February de 2025441

Medline Integrated Arterial Catheters continuously monitor blood pressure. Excess material on the catheter hub that may detach and enter the patient.

http://www.fda.gov/medical-devices/medical-device-recalls/arterial-catheter-recall-medline-industries-lp-removes-integrated-arterial-catheters-due-excess

rss

Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular

Murilo Freitas - 05:00, 5 de February de 2025219

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-atherectomy-catheter-system-issue-bard-peripheral-vascular

rss

FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices

Murilo Freitas - 16:35, 4 de February de 2025342

FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
http://www.fda.gov/news-events/press-announcements/fda-alerts-patients-potential-miss-critical-safety-alerts-due-phone-settings-when-using-smartphone

rss

Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable

Murilo Freitas - 05:00, 4 de February de 2025258

Baxter Healthcare is recalling the Life2000 Ventilator System by correction, due to a defective battery charger making the ventilator inoperable.

http://www.fda.gov/medical-devices/medical-device-recalls/continuous-ventilator-correction-baxter-healthcare-corporation-issues-correction-life2000-ventilator

rss

FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes

Murilo Freitas - 05:00, 4 de February de 2025231

The FDA is alerting users of diabetes-related medical devices that smartphones connected to diabetes devices may fail to send critical safety alerts.

http://www.fda.gov/medical-devices/safety-communications/fda-alerts-patients-regularly-check-diabetes-related-smartphone-device-alert-settings-especially

rss

Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire

Murilo Freitas - 05:00, 4 de February de 2025377

JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD is recalling certain devices due to incidents of device melting and fire during the use of oxygen concentrators.

http://www.fda.gov/medical-devices/medical-device-recalls/oxygen-concentrator-recall-jiangsu-jumao-x-care-medical-equipment-co-ltd-removes-jmc5a-nitruaire-5

rss

Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks

Murilo Freitas - 05:00, 2 de February de 2025438

Becker and Exacta EDMS are used for draining and monitoring cerebrospinal fluid in the brain. Stopcocks may have cracks or leaks that pose a risk to patients.

http://www.fda.gov/medical-devices/medical-device-recalls/pressure-monitoring-device-recall-medtronic-neurosurgery-issues-correction-becker-and-exacta

rss

Update on Alert: Infusion Pump Issue from Fresenius Kabi USA

Murilo Freitas - 05:00, 30 de January de 2025206

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls/update-alert-infusion-pump-issue-fresenius-kabi-usa

rss

Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation

Murilo Freitas - 05:00, 30 de January de 2025181

Mercury Medical recalls the Neo-Tee T-Piece Resuscitator due to the controller potentially not delivering the pressure levels needed for effective ventilation.

http://www.fda.gov/medical-devices/medical-device-recalls/gas-powered-emergency-resuscitator-recall-mercury-medical-removes-neo-tee-t-piece-resuscitator-due