Blog – Page 44 – PRAIS 2.0

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PAHO calls on Latin American and Caribbean countries to improve access to essential cancer medicines and supplies

admin - 17:20, 2 de February de 2025323

PAHO calls on Latin American and Caribbean countries to improve access to essential cancer medicines and supplies

Cristina Mitchell

3 Feb 2025

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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 2025458

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

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Update on Alert: Infusion Pump Issue from Fresenius Kabi USA

Murilo Freitas - 05:00, 30 de January de 2025221

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

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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 2025194

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

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Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

Murilo Freitas - 05:00, 30 de January de 2025192

Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal s

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alvogen-issues-voluntary-nationwide-recall-one-lot-fentanyl-transdermal-system-25-mcgh-due-defective

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FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

Murilo Freitas - 22:44, 29 de January de 2025325

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
http://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain

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Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results

Murilo Freitas - 05:00, 29 de January de 2025325

StatStrip Hospital Glucose and Ketone Meters provide blood glucose and ketone readings in health care settings. A software issue may transmit inaccurate results to patient records.

http://www.fda.gov/medical-devices/medical-device-recalls/glucose-and-glucoseketone-meter-correction-nova-biomedical-corporation-issues-software-correction

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Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 Forceps/Irrigation Plug

Murilo Freitas - 05:00, 29 de January de 2025230

Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-medical-device-advisory-notice-use-alternative-devices-maj-891-forcepsirrigation-plug

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