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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.
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Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag
Dr. Reddy’s Laboratories Ltd is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States.
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Director de la OPS se reúne con el nuevo Secretario General electo de la OEA, Albert Ramdin, para discutir el Sistema Interamericano y las prioridades de salud en las Américas
PAHO Director meets with newly elected OAS Secretary General Albert Ramdin to discuss the Interamerican System and health priorities in the Americas
Cristina Mitchell
11 Mar 2025
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FDA Roundup: March 11, 2025
FDA Roundup: March 11, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-11-2025
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Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals – Due to Increased Reports of Allergic/Hypersensitivity Reactions
As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
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Smiths Medical Issues Urgent Medical Device Correction Informing Customers of a Potential Issue with Certain Sizes of Intubation ORAL/NASAL Endotracheal Tubes Being Smaller Than Expected
Smiths Medical has issued an Urgent Medical Device Correction to notify affected global customers of a potential issue with the 2.0, 2.5, 3.0 and 3.5 mm sizes of Intubation ORAL/NASAL Endotracheal Tube products being smaller than expected.
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FDA Roundup: March 7, 2025
FDA Roundup: March 7, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2025