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Update on Alert: Infusion Pump Issue from Baxter Healthcare Corporation
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Infusion Pump Software Correction: Becton, Dickinson and Company (BD) Issues Correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Due to Risk for Outdated Automated Programming Requests to Load
Software from Alaris System Manager and CCE Infusion Adapter needs updates so outdated infusion information does not load to the Alaris infusion pump system.
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Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause Separation
A manufacturing error may cause ProPort Plastic Implantable Ports, which are used in patients who need repeat venous access for treatment, to separate before, during, or after implantation.
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PAHO ultra-portable telehealth kit brings specialist primary healthcare services to remote communities in the Americas
PAHO ultra-portable telehealth kit brings specialist primary healthcare services to remote communities in the Americas
Cristina Mitchell
18 Mar 2025
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FDA Roundup: March 18, 2025
FDA Roundup: March 18, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-18-2025
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HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families
HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families
http://www.fda.gov/news-events/press-announcements/hhs-fda-announce-operation-stork-speed-expand-options-safe-reliable-and-nutritious-infant-formula
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Embolization Device Recall and Correction: Medtronic Removes Unused 027 Compatible Pipeline Vantage Embolization Device with Shield Technology, Updates Use Instructions for 021 Compatible Pipeline Vantage Embolization Devices due to Increased Risk of Incomplete Wall Apposition and Braid Deformation
Pipeline Vantage Embolization Devices block off blood flow to intracranial aneurysms. Some devices do not attach properly or fail to stay attached.
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FDA Roundup: March 14, 2025
FDA Roundup: March 14, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-14-2025
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FDA Educational Efforts Prevented Nearly 450,000 Youth from Starting E-Cigarette Use in One Year
FDA Educational Efforts Prevented Nearly 450,000 Youth from Starting E-Cigarette Use in One Year
http://www.fda.gov/news-events/press-announcements/fda-educational-efforts-prevented-nearly-450000-youth-starting-e-cigarette-use-one-year
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Disruptions in Availability of Hemodialysis Bloodlines – Letter to Health Care Providers
The FDA is adding hemodialysis bloodlines (also referred to as set, tubing, blood, with and without anti-regurgitation valve; product code FJK) to the Medical Device Shortage List because of recent supplier issues.
